Precision for Medicine

Oversee clinical trial operations, develop study documents, manage site feasibility and enrollment, and ensure compliance with GCP and regulatory standards. | Minimum 7 years of clinical research experience, knowledge of ICH-GCP, and experience in pharmaceutical or device research. | Position Summary: Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies per defined scope of work and ensures that clinical studies are conducted in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP and all applicable regulatory requirements. Essential functions of the job include but are not limited to: Primary clinical point of contact with the client Collaborate with PM on monthly invoicing and variance management of clinical budget Develop study related clinical documents (e.g. clinical plans, Informed Consent Form templates, study specific forms and manuals, CRF completion guidelines, study trackers, PSV/SIV slides and other training materials) Identify and develop training needs for CRAs and third-party vendors specific to the study, protocol and practices including presenting these at Investigator Meetings and Study Kick-off meetings Generate potential site list from key stakeholders and drive site feasibility process Identify potential risks to the enrollment targets based on feasibility analysis and site’s contracted commitment Develop and finalize the country recruitment/retention strategy Develop timely and effective communication and good working relationships with investigators and study team to ensure effective and timely feasibility, site start up, enrollment, maintenance and close out procedures Lead internal clinical team meetings and sets expectations for clinical team of CRAs and CTAs Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log as appropriate Support in planning and conducting investigator meetings Review and/or approve of IP release packages Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees in conjunction with regulatory departments as applicable Develop clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables Generate and utilizes metric reporting (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports) to ensure that the study is conducted per plan and communicates issues to PM and CRAs as appropriate Responsible for eTMF implementation and management Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) and is accountable for implementation and timely closure Accountable to assist sites, internal staff and CRAs with the preparation for GCP audits Work closely with PM for project-specific resourcing issues Escalate pertinent CRA performance and site compliance issues when necessary Collaborate with data management and CRAs to ensure data quality and compliance with data cleaning timelines Manage processes for investigational product (IP) including drug accountability and reconciliation When a cross-functional PM is not assigned to a given program, the CTM will assume project management responsibility as needed Support business development and marketing activities as appropriate May negotiate site budget and investigator contract with support from the legal department and/or site contracts group May review site visit reports and ensures monitoring (i.e. scheduling and scope) is executed per monitoring plan May be responsible for management of clinical vendors (e.g. labs, IP, patient diary, home health care) in conjunction with PM May perform clinical data review of patient profiles, data listings and summary tables, including query generation May have line management responsibilities Performs other duties as assigned by management Qualifications: Minimum Required: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred Minimum of 7 years of clinical research experience or proven competencies for the position with significant clinical monitoring experience Preferred: Advanced degree Other Required: Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Excellent communication and interpersonal skills to effectively interface with others in a team setting Excellent organizational skills, attention to detail, and a customer service demeanor Ability to travel domestically and internationally including overnight stays Competencies: Demonstrates mastery knowledge of ICH-GCP, relevant Precision SOPs, and regulatory guidance, as well as the ability to implement Working knowledge of clinical management techniques and tools Direct work experience in a cross-functional environment Proven experience in functional management including proven experience in delegating while fostering cohesive team dynamics Proven experience in planning, risk management and change management High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective Ability to lead and inspire excellence within a team Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency Results oriented, accountable, motivated and flexible Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills Excellent presentation, verbal and written communications skills In depth proven experience in pharmaceutical and/or device research required Demonstrated successful independent negotiation and conflict management strategies Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $110,700—$166,100 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Manage and oversee clinical study projects ensuring quality, scope, budget, and timeline adherence. | Requires 7+ years of clinical research experience, project management skills, and familiarity with clinical trial software and regulations. | The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Essential functions of the job include but are not limited to: Serve as primary point-of-contact and primary escalation point to the client Coordinate and oversees all functional services including external vendors to the established timeline and budget Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed. Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives. Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings. Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation Establish tracking metrics to monitor trial and team progress towards project goals Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise Leads both internal and client meetings and set expectations for the project team Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defences with proficiency Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required Perform other duties as assigned by management Remain compliant with organisational training, time-reporting and any other administrative duties as required Provides on-going feedback, for functional team members including annual performance reviews Qualifications: Minimum Required: North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience Experience in managing complex and global trials Ability to travel domestically and internationally including overnight stays Other Required: Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project, eTMF, EDC and CTMS Proven communication and interpersonal skills to effectively interface with others in a team setting Proven organizational skills, attention to detail, and a customer service demeanour Competencies: Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items Proven knowledge of project management techniques aPay transparencynd tools Direct work experience in a global, cross-functional project management environment Good understanding of cross-functional management Good understanding of project planning, risk management and change management with an awareness of appropriate escalation Proven experience in strategic planning, risk management and change management High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective Ability to lead and inspire excellence within a study team Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency Results oriented, accountable, motivated and flexible Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills Proven presentation, verbal and written communications skills Good understanding of project management software In depth proven experience in pharmaceutical and/or device research required Preferred: experience with oncology & cell and/or gene therapy #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $147,300—$220,900 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Manage and oversee clinical study projects ensuring quality, scope, and budget adherence, and coordinate with various stakeholders. | Requires 7+ years in clinical research or project management, experience with global trials, and knowledge of clinical research tools and regulations. | The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Essential functions of the job include but are not limited to: Serve as primary point-of-contact and primary escalation point to the client Coordinate and oversees all functional services including external vendors to the established timeline and budget Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed. Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives. Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings. Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation Establish tracking metrics to monitor trial and team progress towards project goals Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise Leads both internal and client meetings and set expectations for the project team Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defences with proficiency Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required Perform other duties as assigned by management Remain compliant with organisational training, time-reporting and any other administrative duties as required Provides on-going feedback, for functional team members including annual performance reviews Qualifications: Minimum Required: North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience Experience in managing complex and global trials Ability to travel domestically and internationally including overnight stays Other Required: Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project, eTMF, EDC and CTMS Proven communication and interpersonal skills to effectively interface with others in a team setting Proven organizational skills, attention to detail, and a customer service demeanour Competencies: Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items Proven knowledge of project management techniques aPay transparencynd tools Direct work experience in a global, cross-functional project management environment Good understanding of cross-functional management Good understanding of project planning, risk management and change management with an awareness of appropriate escalation Proven experience in strategic planning, risk management and change management High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective Ability to lead and inspire excellence within a study team Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency Results oriented, accountable, motivated and flexible Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills Proven presentation, verbal and written communications skills Good understanding of project management software In depth proven experience in pharmaceutical and/or device research required Preferred: experience with oncology & cell and/or gene therapy #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $147,300—$220,900 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Support project teams financially and assist with general ledger functions, including invoicing, variance analysis, and contract review. | Requires 5+ years in general ledger, financial reporting, project budgets, and CPA qualification, with CRO industry experience preferred. | Position Summary: This position is a hybrid between a project budget analyst supporting the operational project teams financially, and an accountant supporting all general ledger functions and the month-end close cycle. Essential functions of the job include but are not limited to: Support the project teams in all financial areas associated with running a clinical trial. Assist in the preparation of the monthly invoicing worksheet which is the source document for client invoicing and source of revenue recognition Perform variance analysis comparing forecasted revenue to actual revenue to identify gaps, changes in scope, etc. Review work orders and change order budgets in comparison with actual activities to help identify out of scope activities Perform monthly Earned Value Analyses (EVA’s) in conjunction with the Project Directors/Project Managers. Participate in the monthly project review meetings on an as needed basis Provide support to the Executive Director of Operational Finance in the preparation of contract documents (statements of work and change orders) Work with Company Accountant to provide support to the financial reporting and general ledger functions. Work with Company Accountant to provide support to ensure an accurate and timely monthly, quarterly and year-end close Work with Company Accountant to ensure the timely reporting of all monthly financial information. Collaborate with others in Finance to support overall department goals and objectives Responds to inquiries from the CFO and Executive Director of Operational Finance regarding financial results, special reporting requests and ad hoc analyses relating to projects Assist in development and implementation of new procedures and features to enhance the workflow and internal controls Qualifications: Minimum Required: Bachelor’s degree in Accounting/Finance or related business field Other Required: Five or more years general ledger and financial reporting experience including working knowledge of all areas of the accounting cycle, project budgets, financial project management support, Earned Value Analysis (“EVA”) analysis, and contract review or equivalent relevant experience and/or demonstrated competencies Ability to undertake occasional domestic and international travel including overnight stays Certified Public Accountant (CPA) for North America or equivalent local qualification CRO industry experience Quick Books Competencies: Strong Working knowledge of the life cycle of a project with a solid foundation of how the financials and contract status impact each stage of the clinical trial Working knowledge of accounts payable, accounts receivable, general ledger, bank reconciliations, QuickBooks or related software package, strong Excel /PC skills and able to thrive in multi-tasking environment Strong accounting skills High energy and enthusiasm with a strong commitment to exceeding expectations Flexibility and willing to work on multiple assignments of varying tasks with personnel throughout the organization Ability to learn quickly. Good oral and written communication & interpersonal skills with the ability to connect and build relationships with management and others throughout the organization Exhibits self-motivation, and is able to work independently as well as in a team environment Team player with a desire to be an active, long-term participant in the growth of the company #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $83,200—$124,800 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Lead and oversee global clinical trial projects, manage teams, and ensure project objectives are met efficiently. | Extensive experience in clinical research project management, leadership skills, knowledge of GCP/ICH guidelines, and ability to manage complex, global trials. | Position Summary: Manages and provides leadership to Directors, drives strategy to plan, coordinate, and deliver all activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Essential functions of the job include but are not limited to: Work with Senior Leadership to support defined corporate and departmental business strategies for Precision Direct, manage and ensure collaboration within a team of Directors, Project Directors and Project Managers in the planning, execution and governance of projects/portfolios on a global platform Provide leadership and oversight on all programs including large programs or programs that are increasingly complex (in scope, revenue contribution, volume and design) Interact with study sponsors as primary point of escalation beyond project management Optimize the profitability of the Project Management organization to meet or exceed budget targets Assess and manage resource allocations to ensure that established cost, time, and quality goals are met Select, train, develop and manage the performance of talent in project leadership positions (Directors, Project Directors and Project Managers) Provide technical support and guidance (including scope definition, risk identification, escalation and mitigation, resource planning, goals and deliverables) to assigned project managers Identify and escalate impacts to project scope, resources, schedule or budget through standard methods Ensure project leadership personnel work to the highest quality standards and maintain compliance with established SOPs, working guidelines, project plans and all regulatory requirements Participate with Business Development in opportunity development, proposals and budgeting, bid defense preparation and attendance Understand and manage project/program inter-dependencies to achieve program milestones/deliverables Conduct evaluations and implement required changes for all projects (including mid-project recovery of at risk projects, re-scoping, postponement, or cancellation) Measure and report KPIs and lead continuous improvement Recognize, exemplify and adhere to Precision’s values that center on our commitment to quality, our people, clients and performance May function as Executive Oversight for projects not assigned as DPM • Manages workload of supervised staff with continued assessment and adjustment as needed Provides on-going feedback, development and coaching of Directors, Project Directors and Project Managers including annual performance reviews Qualifications: Minimum Required: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred. A minimum 15 years of experience in clinical research, including extensive project management and line management experience or proven competencies for this position Working knowledge of GCP/ICH guidelines and the clinical development process Other Required: Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) and Microsoft Project Excellent communication and interpersonal skills to effectively interface with others in a team setting Excellent organizational skills, attention to detail, and a customer service demeanor Ability to travel domestically and internationally including overnight stays Preferred: Advanced degree Experience in managing complex and global trials Competencies: Working knowledge of project management techniques and tools Direct work experience in a global, cross-functional project management environment Proven experience in people management Proven experience in strategic planning, risk management and change management Ability to work closely with business unit leadership to understand customer's needs Strong analytical skills and business acumen Executive presence with ability to confidently deliver complex presentations to senior management High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective. Demonstrated leadership track record and effective interpersonal skills Ability to lead and inspire excellence within a team Ability to create an environment where employees have a sense of ownership that will lead to increases in productivity and efficiency Results oriented, accountable, motivated and flexible Excellent time management, negotiation, critical thinking, decision making, analytical and interpersonal skills Excellent presentation, verbal and written communications skills • Proficient in project management software In depth proven experience in pharmaceutical and/or device research required Excellent Planning and organizing Excellent Influencing and leading Proven experience in delegating while fostering cohesive team dynamics Demonstrated successful independent negotiation and conflict management strategies #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $203,400—$304,800 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Manage and coordinate clinical study projects ensuring quality, scope, and budget adherence. | Minimum of 7 years in clinical research or project management, experience with global trials, and proficiency in project management tools. | The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Essential functions of the job include but are not limited to: • Serve as primary point-of-contact and primary escalation point to the client • Coordinate and oversees all functional services including external vendors to the established timeline and budget • Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed. • Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities • Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives. • Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality • Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings. • Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation • Establish tracking metrics to monitor trial and team progress towards project goals • Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise • Leads both internal and client meetings and set expectations for the project team • Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues • Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defences with proficiency • Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project • Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required • Perform other duties as assigned by management • Remain compliant with organizational training, time-reporting and any other administrative duties as required • Provides on-going feedback, for functional team members including annual performance reviews Qualifications: Minimum Required: • North America: Bachelor's degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred • EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred • Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience • Experience in managing complex and global trials • Ability to travel domestically and internationally including overnight stays Other Required: • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project, eTMF, EDC and CTMS • Proven communication and interpersonal skills to effectively interface with others in a team setting • Proven organizational skills, attention to detail, and a customer service demeanor Competencies: • Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items • Proven knowledge of project management techniques and tools • Direct work experience in a global, cross-functional project management environment • Good understanding of cross-functional management • Good understanding of project planning, risk management and change management with an awareness of appropriate escalation • Proven experience in strategic planning, risk management and change management • High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective • Ability to lead and inspire excellence within a study team • Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency • Results oriented, accountable, motivated and flexible • Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills • Proven presentation, verbal and written communications skills • Good understanding of project management software • In depth proven experience in pharmaceutical and/or device research required • Preferred: experience with oncology & cell and/or gene therapy #LI-Remote Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Oversee validation, compliance, and quality governance of systems in a regulated environment, ensuring audit readiness and regulatory adherence. | Minimum 10 years of experience in clinical research QA or related fields, with strong knowledge of CSV, GxP, and regulatory guidelines, plus leadership experience. | Position Summary: The Director of Quality Assurance (QA) Systems is responsible for ensuring the validation, integrity, and compliance of systems across Precision for Medicine (PFM). This role oversees the development, implementation, and maintenance of QA strategies and processes that support regulatory requirements, industry standards, and internal policies. The Director will lead cross-functional teams to ensure systems are validated, documented, and maintained in a state of control, enabling consistent compliance with global quality standards. While working closely with the Technical Services team, the Director QA Systems reports to the VP, Global Quality Assurance – Translational Sciences. Essential functions of the job include but are not limited to: System Validation & Compliance Oversee the PFM risk-based Computer System Validation planning and execution (e.g., Validation Plans, Requirements Traceability Matrix, IQ/OQ/PQ, UAT), aligned to 21 CFR Part 11, EU Annex 11, ICH E6(R3) GCP, GLP, and data integrity principles (ALCOA++). Ensure all computerized systems are validated according to internal SOPs and regulatory expectations. Maintain a robust risk-based approach to system validation and lifecycle management by assuring periodic review, change control, configuration management, and release readiness for validated systems. Supports lifecycle controls from implementation through decommissioning. Quality Governance Establish and enforce QA policies and procedures for PFM systems. Provides input to the Application Development Lifecycle (ADLC) processes to represent regulated technologies Monitor compliance trends and implement continuous improvement initiatives. Serve as the primary key liaison with regulatory agencies and third parties for system-related audits and inspections. Supports the maintenance of inspection ready validation documentation Leadership & Collaboration Partner with Security, Development, PMO, BRM, Business Analysts, DevOps, Clinical Ops, and Lab leaders to prioritize QA activities and embed quality into SDLC/DevOps pipelines Act as a key liaison with regulatory agencies during inspections related to corporate systems. Deliver training and coaching on validation, testing, and data integrity for system owners and study teams Partake to the qualification of data/system service providers Documentation & Reporting Ensure accurate and timely documentation of validation activities, deviations, and corrective actions. Provide regular compliance reports and metrics to senior leadership. Maintain audit readiness for all corporate systems. Collaboratively work with IT to respond to audit findings. Qualifications: Minimum Required: Requires 10 years of experience in clinical research with emphasis in Quality Assurance / Compliance Strong knowledge of computerized systems validation (CSV) Experience working on CSV activities in a GxP environment Strong knowledge of ICH guidelines, 21 CFR Part 11, EU Annex 11 and OECD guidelines. Supervisory/management experience leading quality personnel Proven leadership experience managing QA teams and cross-functional projects. Excellent communication, problem-solving, and organizational skills. Other Required: Bachelor’s degree in a science, healthcare or related field of study Availability to travel up to 25% domestically and/or internationally Experience leading audits Preferred: Graduate, postgraduate degree, ideally in a scientific or healthcare discipline CRO, Pharmaceutical and/or medical device experience Experience hosting client/Health Authority inspections Skills: Strong leadership skills, excellent interpersonal and problem-solving skills, strong verbal and written communication, excellent computer skills Clinical project proposals and budget forecasting Competencies: Ability to effectively communicate across the organization on quality topics Represents Quality in sponsor discussions Resolves project related problems and prioritize workload to meet deadlines with little support from management Exhibits high self-motivation and can work and plan independently as well as in a team environment Motivates other members of the project team to meet timelines and project goals Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective Proven ability to communicate with senior management, external thought-leaders and operational staff Ability to work with cross functional groups and management under challenging situations Ability to prioritize work and handle multiple and/or competing assignments Excellent verbal and written communications skills #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $162,000—$243,000 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Oversee clinical trial laboratory operations ensuring regulatory compliance, assay development, quality control, and cross-functional collaboration. | Master’s or PhD in clinical/laboratory science with 10+ years leadership in tissue-based lab testing and clinical trial environment, plus experience with specific lab technologies and regulatory standards. | Summary The Director of Laboratory Operations, Anatomic Pathology will oversee clinical trial testing for phases I, II, and III using Immunohistochemistry (IHC), in situ hybridization (ISH), and multiplex immunofluorescence (mIF) methodologies. The Director will oversee a team of scientists and technologists who develop and validate assays to Sponsors’ specifications, and will deliver test results for clinical trial studies on time and with high quality. The Director of Laboratory Operations, Anatomic Pathology will oversee delivery for multiple, concurrent studies, and will work across functions (Project Management, Data Management, Quality Assurance, Environmental Health and Safety) to comply with contractual and regulatory requirements. Key Responsibilities: Oversee laboratory operations, ensuring adherence to CAP/CLIA regulations, and GCLP standards Develop and implement strategies for improving workflow, quality control, and patient safety Collaborate with clinical, administrative, and operational leaders to align laboratory services with organizational goals Evaluate and optimize Laboratory Information Management Systems (LIMS) Direct complex technical projects, including assay development and validation for IHC, ISH, and/or mIF testing, process standardization, and quality improvement initiatives Evaluate assay platforms and software to facilitate testing, imaging, and reporting Work with Quality Assurance to perform assay, platform, and software validations Work with Quality Assurance to investigate deviations and non-conformances Perform duties as delegated by the Medical Director of the laboratory Qualifications: Education: Master’s degree in clinical science, laboratory science, chemistry, biology, or related field, PhD Preferred Experience: 10+ years of progressive leadership in laboratory operations 10+ years of experience in tissue-based laboratory testing 5+ years in clinical trial testing environment Experience with automated stainers (e.g. Leica Bond systems) Experience with imaging systems (e.g. Vectra Polaris, Aperio) Experience with image analysis software (e.g. HALO, PathAI, Visiopharm) Preferred Experience with mIF assay development and validation Experience with Design Control as per 21CFR820 Skills: Strong financial acumen, including budget management and workforce planning Knowledge of Lean, Six Sigma, or other process improvement methodologies preferred Experience with Laboratory Information Management Systems (LIMS) is a plus Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $147,300—$220,900 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.

Plan, direct, coordinate, and deliver clinical study projects ensuring quality, scope, cost, and time objectives are met while managing budgets, vendors, and cross-functional teams. | Bachelor’s degree in science or health-related field, 7+ years clinical research experience, 4+ years project management, experience with global trials, and proficiency with clinical trial management tools. | The Senior Project Manager plans, directs, coordinates, and delivers activities for designated clinical study projects to ensure that project objectives of quality, scope, cost, and time are accomplished. Essential functions of the job include but are not limited to: Serve as primary point-of-contact and primary escalation point to the client Coordinate and oversees all functional services including external vendors to the established timeline and budget Manage the study budget, ensuring project remains within scope and that any out of scope activities are identified early and handled as appropriate. Independently drive the CO to completion and execution with support as needed. Maintain integrated collaboration with clinical operations in the delivery and participates in clinical activities as appropriate. For projects of very limited scope (i.e. number of sites), Sr. PM may assume all clinical activities Manage the financial health of assigned studies, including oversight of the project profitability, billable project hours, and compliance with on time, accurate billing and forecasting to support business objectives. Develop robust and comprehensive project plans, including timelines and proactive risk management and mitigation, to guide all parameters of trial execution with consistency and quality Ensure Quality management for assigned projects, including eTMF Inspection readiness, implementation of quality notification incident forms and / or corrective and preventative action plans to address any quality findings. Maintain integrated collaboration with all functional operations in the delivery of the program and review as necessary of other study documentation Establish tracking metrics to monitor trial and team progress towards project goals Prepare project status updates and report on progress to clients and senior management, including reporting on key performance indicators, offering solutions and opportunities as they arise Leads both internal and client meetings and set expectations for the project team Communicate effectively with client and Precision management to relay protocol/study issues including any deviations and implements necessary actions in response to those issues Ability to conduct formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients including Bid Defenses with proficiency Ensure study specific training is implemented in collaboration with functional areas and ensure study specific training compliance for the duration of the project Support business development and marketing activities as appropriate, including travel to Bid Defense meetings as required Perform other duties as assigned by management Remain compliant with organizational training, time-reporting and any other administrative duties as required Provides on-going feedback, for functional team members including annual performance reviews Qualifications: Minimum Required: North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred EU: Degree or equivalent combination of education/experience in science or health-related field. Advanced degree preferred Minimum of 7 years of clinical research experience or proven competencies for this position and a minimum of 4 years of direct project management experience Experience in managing complex and global trials Ability to travel domestically and internationally including overnight stays Other Required: Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) Microsoft Project, eTMF, EDC and CTMS Proven communication and interpersonal skills to effectively interface with others in a team setting Proven organizational skills, attention to detail, and a customer service demeanour Competencies: Demonstrates knowledge of ICH-GCP, relevant Precision SOPs, as well as the ability to implement such items Proven knowledge of project management techniques and tools Direct work experience in a global, cross-functional project management environment Good understanding of cross-functional management Good understanding of project planning, risk management and change management with an awareness of appropriate escalation Proven experience in strategic planning, risk management and change management High level of integrity and must inspire and demand the highest standards from a professional and ethical perspective Ability to lead and inspire excellence within a study team Ability to create an environment where study team members have a sense of ownership that will lead to increases in productivity and efficiency Results oriented, accountable, motivated and flexible Proven time management, negotiation, critical thinking, decision making, analytical and interpersonal skills Proven presentation, verbal and written communications skills Good understanding of project management software In depth proven experience in pharmaceutical and/or device research required Preferred: experience with oncology & cell and/or gene therapy #LI-Remote Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits. Reasonable estimate of the current range $125,200—$187,800 USD Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice. Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR@precisionmedicinegrp.com. It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.