ClinChoice

Manage clinical study delivery per protocols and regulations, oversee data compliance, and train junior staff. | Bachelor's or advanced degree in scientific discipline with 3-5 years managing medical device clinical projects, especially in sleep and respiratory studies, and strong organizational and communication skills. | Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is seeking a Clinical Project Manager II to partner with one of our sponsors in leading a clinical sleep study. This role requires demonstrated experience managing medical device clinical trials, with a strong preference for respiratory study experience. The ideal candidate will bring expertise in overseeing study execution, ensuring regulatory compliance, and driving cross-functional collaboration to deliver high-quality results on time and within scope. This role is a w-2 contract role. ClinChoice is a global full-service CRO with a strong focus on quality and professional development. As a client-facing role, we are looking for confident candidates with the ability to work independently while establishing a high-trust environment with their client counterparts. Main Job Tasks and Responsibilities: Manages the delivery of study requirements to the protocol and regulations such as GCP and ISO 14155, the site needs and the required timelines set for the project. Apply principles, concepts and techniques for effective and proactive project management of a clinical study. Balances resource constraints (i.e. time, money, people, and equipment) against deliverables. Develop clinical study budget and may assist in quarterly departmental budget reviews. Seeks input from higher-level clinical experts or program management as issues warrant. Leverage experience and work with collaborative team members to recommend and implement methods for improving processes and addressing issues within the clinical operations department. Implement and maintain risk-based monitoring processes to drive efficient and effective study management. Oversee and review data and/or monitoring reports for protocol violations and serious protocol deviations, and proactively address violations/deviations, to assure protocol and GCP compliance. Train and mentor more junior staff on monitoring, internal procedures, and query resolution to assure alignment and GCP compliance. Education, Experience and Skills: Bachelor's or advanced degree in a relevant scientific discipline. 3-5 years of medical device clinical project management experience. Experience with sleep and respiratory studies are required. In-depth knowledge of ICH-GCP, EMEA guidelines and other relevant regulations and guidelines. Proven ability to manage clinical studies within timelines and budgets while maintaining high quality standards and patient safety. Ability to proactively develop risk management and mitigation plans in country and resolve issues locally. Effective and efficient time management, organizational and interpersonal skills, conflict management and problem-solving skills. High sense of accountability and urgency to prioritize deliverables. Strong communication skills and negotiation skills as well as excellent influencing and training/mentoring, both written and verbal. Ability to focus on multiple deliverables and protocols simultaneously is essential. Positive mindset, growth mindset, capable of working independently and being self-driven. Able to directly influence Clinical Operations staff. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical devices, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset, and they are the fulcrum around which all ClinChoice activities are built, and close management and training is the core instrument to develop and maintain highly-qualified personnel. Continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. Key Words: Clinical Study Management, Clinical Project Management, Clinical Operations, Study Delivery, Protocol Compliance, GCP (Good Clinical Practice), ISO 14155, Risk-Based Monitoring (RBM), Study Timelines, Resource Management, Budget Development, Budget Oversight, Clinical Study Budgeting, Protocol Deviations, Serious Adverse Events (SAE) Oversight, Regulatory Compliance, Audit Readiness, Monitoring Reports Review, Data Review & Oversight, Quality Assurance, Inspection Preparedness, Cross-Functional Collaboration, Site Management, Monitoring Oversight, Query Resolution, Risk Management, Vendor Management, Study Start-Up & Close-Out, Clinical Trial Lifecycle Management, Medical Devices, Respiratory, Sleep Studies #LI-VH #LI-Remote #Project Manager # Contract

Developing and overseeing statistical aspects of clinical trial protocols, ensuring data quality, and mentoring statisticians. | MS or PhD in Statistics or Biostatistics with 4-5 years of experience, strong oncology TA experience, and industry knowledge including FDA regulations. | Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds…. ClinChoice is searching for a Senior Biostatistician Consultant to join one of our clients. ClinChoice is a global full-service CRO with a strong focus on quality, professional development, and supportive culture. As a client-facing role, we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts. Main Job Tasks and Responsibilities: Responsible for protocol development including study design, sample size calculation, randomization, and statistical analysis plan for assigned studies. Provide statistical oversight to studies and assure adequate quality and consistency with project requirements. Responsible for assuring that data for statistical analyses are complete, accurate and consistent. Responsible for statistical analysis plans and the accuracy and timeliness of statistical input into reports or decisions. Responsible for validity of analysis and explore alternative analysis strategies as needed. Demonstrates extensive understanding of statistical concepts and methodologies. Recognizes and corrects flaws in scientific reasoning and statistical interpretation. Responsible for accuracy and consistency of statistical tables, figures, and data listings, accuracy of report text, and consistency between summary tables in the body of reports and the corresponding source tables and listings. Responsible for statistical methods section for the reports. Identifies and corrects common flaws in interpretation of results, inconsistency in presentation or inference, adherence to the report guidelines, and assures project-wide consistency. Effectively mentor peers with regards to statistical methodology and provide appropriate training to less experienced statisticians. Manage activities of statisticians across projects by appropriately coordinating assignments and reviewing work so that projects are delivered on time with high quality. Education and Experience: MS or PhD in Statistics, Biostatistics or related field. PhD with 2-3 years of experience or MS with 4-5 years of experience. Strong experience with Oncology TA. Strong oral and written communications skills, with ability to effectively communicate internally and with clients. Demonstrated understanding and insight in statistics, drug development process and relevant FDA regulations. Pharmaceutical, CRO, or related industry experience with clinical trials, including interaction with Regulatory Agencies, especially FDA. The Application Process Once you have submitted your CV, you will receive an acknowledgement that we received it. If you have the requirements we need, you will be invited for phone interview as the first step. Unfortunately, due to the number of applications we receive, we cannot reply to everyone individually if you are not successful. Who will you be working for? About ClinChoice ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical, biotechnology, medical device, and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services, with over 4,000 professionals in more than 20 countries across the Americas, Europe, and Asia-Pacific. Our Company Ethos Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology. The success of these core values is evidenced by our below industry average turnover rates. ClinChoice is an equal opportunity employer. We have based our success on attracting, developing, and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender, race, beliefs, and ethnicities. We recognize this is our strength and celebrate it. #LI-TT1 #LI-Remote #Senior#Contract