Position Summary: The Clinical Trial Manager (CTM) provides oversight of clinical trials according to all applicable regulations and guidance, ICH/GCP and SOPs. The CTM participates in cross-functional team and partners with internal and external team members/key stakeholders ensuring alignment of activities with study projects and timelines.
Primary Duties and Responsibilities: Manages clinical trials and data collection Establishes scientific methods for design and implementation of clinical protocols, data collection systems and final reports Monitors adherence to protocols and determines study completion Monitor study sites and activities to ensure the protocol and terms of the study are being followed Identifying, managing and collaborating with contract research organizations (CROs) and other study personnel Identifying, evaluating and establishing trial sites and closing sites down upon completion of trial Tracking and following up on enrollment, discontinuation and completion of study subjects Proactively identifies and resolves operational issues/processes to ensure achievement of study milestones, data quality, and data integrity; escalates study-related issues appropriately in a timely manner Obtain and relay key study issues, status updates, and other study information to the clinical trial team and management Manages recruitment efforts and activities to meet study enrollment goals and timelines, and provides status to upper management Interacts with other functional areas and key stakeholders, including Clinical Development, Data Management, Finance, Regulatory, R&D, Clinical Supply (Investigational Product) and clinical vendors (e.g., central laboratory, CROs), as needed, to support clinical trial activities Provides input on the development of CRF design Liaising with regulatory authorities when applicable Participates in data cleaning, listing, and report output reviews Develops, reviews, and approves study-related manuals, plans, specifications, instructions for use, charters, newsletters, and materials Participates in protocol deviation listing reviews and meetings Responsible for oversight of site study budget, investigator and vendor contracts, budgets and payments Participates in the protocol, table, figure, data listings, and clinical study report reviews Develops presentations for clinical sites, team and investigator meetings Provides oversight for the setup, maintenance, and close-out of the Trial Master File and ensures it is complete and audit-ready May be responsible for a defined region, vendor or process across a program Education/Experience/Skills: Bachelor’s Degree in a life science plus the knowledge and skills typically acquired through a minimum of 3-5 years’ relevant industry experience in medical research, nursing or pharmaceuticals/devices. Minimum 2 years experience on the Sponsor side Experience with data entry, EDC systems, regulatory review and submissions Experience with diagnostics, LDT's preferred Previous clinical work experience that provides the knowledge, skills, and abilities to perform the job Experience utilizing CTMS, EDC, TMS and related software Prior experience in management and monitoring of CRO and investigative sites, preferred Broad knowledge of ICH, GCP, IRB/IEC, and local regulatory authority for diagnostic & assay Excellent written and verbal communication skills Ability to multi-task and re prioritize workflow as necessary Proficient knowledge of Microsoft Office Suite and the ability to learn additional necessary software Additional Information:
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. If you are an individual with a disability and would like to request a reasonable accommodation as part of the employment selection process, please contact Talent Acquisition. APPLY HERE