PSI CRO

Coordinate and oversee clinical trial site activities, ensuring data integrity, compliance, and timely project execution. | Requires at least 4 years of site monitoring experience in clinical trials, preferably in oncology or related fields, with strong communication and organizational skills. | PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description Coordinates investigator/ site feasibility and identification process, as well as study startup. Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. Manages Monitors in the query resolution process, including Central Monitoring observations. Coordinates safety information flow and protocol/process deviation reporting. Performs clinical supplies management with vendors on a country and regional level. Ensures study-specific and corporate tracking systems are updated in a timely manner. Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. Coordinates planning of supervised monitoring visits and conducts the visits. Manages the project team in site contracting and payments. Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. Ensures ongoing evaluation of data integrity and compliance at a country/regional level. Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. Oversees project team in CAPA development and implementation. Coordinates project team in process deviations review, management and reporting. Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. Delivers trainings and presentations at Investigator Meetings. Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits. Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. Ensures data integrity and compliance at a site level. Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. Conducts project-specific training of site Investigators. Supports preparation of draft regulatory and ethics committee submission packages. Qualifications Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience. Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. Experience with all types of monitoring visits in Phase II and/or III. Strong experience in Oncology preferred. Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. Full working proficiency in English. Proficiency in MS Office applications. Ability to plan, multitask and work in a dynamic team environment. Excellent Communication, collaboration, and problem-solving skills. Ability to travel up to 50% (depending on project needs). Valid driver’s license (if applicable). Additional Information If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Lead and manage business development efforts to expand client base and foster long-term relationships in the healthcare industry. | Requires 3-5 years in CRO sales, proficiency with Salesforce, and a university degree in health sciences or equivalent. | We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together approximately 3,000 driven, dedicated and passionate individuals. We work on the front line of medical science, changing lives, and bringing new medicines to those who need them. Job Description We are looking for a Director of Business Development who will expand our existing client base in the United States. Actively prospects and leverages potential new business opportunities within specified Customer/Accounts. Cultivates strong, long-term relationships with key decision-makers with Account and develops deep knowledge of the Customer/Account organization. Analyzes potential opportunities and develops detailed business plans and sales strategies for each Customer/Account. Identifies and responds to Customer/Account needs in order to define potential PSI opportunities. Ensures appropriate strategy/solution is proposed to Customer/Account. Works with Operations to identify sales team and prepare presentation. Educates team participants in Customer/Account culture, operational needs/methods and sales techniques needed to close the sale. Leads the entire sales process, including identifying the appropriate team for pitch and preparing and leading the sales presentation. Coordinates with the Proposal Development Group to develop proposal and Operations to finalize strategy and pricing. Handles follow-up related to the sales and facilitates completion of contractual documents. Ensures appropriate hand-off to project team by transferring knowledge on Customer/Account needs and expectations. Shares Customer/Account strategies and sales plans with Project Directors/Managers. Coordinates with Project Managers/Directors and Operations to escalate and quickly address Customer/Account issues/concerns. Seeks input from Project Managers/Directors to proactively address Change in Scope, new opportunities or customer dissatisfaction Works with Project Manager/Director and Operations to ensure Changes in Scope (CIS’s) are appropriately negotiated with the Customer/Account. Maintains high visibility within Customer/Account organization. Monitors Customer satisfaction through regular formal and informal surveys. Coordinates with Project Managers/Directors to ensure Customer/Account needs are being met and address concerns/issues in a timely manner. Reviews proposals and analyzes requests for proposals and protocols Attends industry events, set up meetings at events, and perform follow-up with potential clients Acts as a liaison between US clients and Operations on an as needed basis Qualifications University degree in health sciences or an equivalent combination of education, training & experience Demonstrable competency in sales or business development preferably for a Contract Research Organization or company providing services to the healthcare industry 3 - 5 years of business development experience in the CRO sales arena Working proficiency with Salesforce Strong communication, collaboration, problem solving, and time management skills Capable and willing to travel Additional Information If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Coordinate and monitor clinical trial sites, manage project timelines, ensure compliance and data integrity, train and mentor monitors, and support regulatory submissions. | Minimum 4 years site monitoring experience in global clinical projects, preferably in oncology or advanced therapies, with strong communication and multitasking skills. | PSI is a leading Contract Research Organization with more than 25 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description Coordinates investigator/ site feasibility and identification process, as well as study startup. Monitors project timelines and patient enrollment, implements respective corrective and preventive measures. Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region. Manages Monitors in the query resolution process, including Central Monitoring observations. Coordinates safety information flow and protocol/process deviation reporting. Performs clinical supplies management with vendors on a country and regional level. Ensures study-specific and corporate tracking systems are updated in a timely manner. Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager. Coordinates planning of supervised monitoring visits and conducts the visits. Manages the project team in site contracting and payments. Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager. Ensures ongoing evaluation of data integrity and compliance at a country/regional level. Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level. Oversees project team in CAPA development and implementation. Coordinates project team in process deviations review, management and reporting. Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs. Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead. Delivers trainings and presentations at Investigator Meetings. Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits. Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level. Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations. Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level. Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level. Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level. Ensures data integrity and compliance at a site level. Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer. Conducts project-specific training of site Investigators. Supports preparation of draft regulatory and ethics committee submission packages. Qualifications Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience. Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. Experience with all types of monitoring visits in Phase II and/or III. Strong experience in Oncology preferred. Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. Full working proficiency in English. Proficiency in MS Office applications. Ability to plan, multitask and work in a dynamic team environment. Excellent Communication, collaboration, and problem-solving skills. Ability to travel up to 50% (depending on project needs). Valid driver’s license (if applicable). Additional Information If you feel it is time to make your skills and knowledge visible within a growing company with true focus on its people, then PSI is the right choice for you. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.

Lead patient recruitment and retention strategies, manage site partnerships, develop patient engagement solutions, and collaborate across departments to improve enrollment metrics. | 10+ years clinical research experience, 5+ years site communication and patient recruitment experience, proficiency in MS Office, and ability to work autonomously. | PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description The Manager Site Relations, titled Manager Patient Recruitment & Retention Strategy, will be responsible for the operations, communication, and development of strategic site partnerships. • Develops global enrollment and retention solutions to increase patient screening, randomization, and compliance • Builds and manages patient engagement service offerings and associated costs for global bids, including vendor and in-house resource allocation • Designs and implements patient engagement assessments for awarded studies, focused on impact measurement, analysis, and mitigation planning • Participates in scientific conferences, meetings, symposia, etc. to collect information on patient access and diversity • Assesses patient enrollment challenges and opportunities in ongoing and completed studies to improve patient recruitment and retention strategies. • Liaises with other PSI departments to collate operational feedback and support patient engagement strategy • Liaises with Project Management to evaluate the impact of recruitment services on patient enrollment metrics for awarded studies • Collaborates with Business Development and Feasibility to identify and illustrate the value-add of prioritized recruitment services • Develops and facilitates training programs to department staff and across key functional areas based on area of expertise Qualifications EDUCATION • University/college degree, ideally in the life science or health care field • MD, PharmD, PhD, or RN qualification is a plus EXPERIENCE • A minimum of 10 years’ experience in clinical research • A minimum of 5 years’ experience in site communication, site relationship management, and patient recruitment; CRO experience preferred • Experience in scientific report writing, independent research, and data analysis SKILLS • Proficiency in standard MS Office applications • Must have critical thinking and problem-solving skills and have the ability to work autonomously • Proficiency in and the ability to learn/work with different databases and software tools Additional Information Advance your career in clinical research and lead challenging full-service projects on the country/regional level while growing with a rapid company, that puts its people first! You will get hands-on involvement in every aspect of the study. For this position, PSI is not hiring individuals who require work visa for employment or continued employment now or anytime in the future.