Freelance Clinical Trial Manager I (Project Associate)
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Proclinical are partnered with an early stage biotech on an exclusive basis to recruit for a Freelance Clinical Trial Manager I (Project Associate) 0.7 FTE in The Netherlands.
The Clinical Trial Manager I (Project Associate) will have the responsibility of assisting the Study Management team in overseeing the daily functional activities of Clinical Operations related to the implementation of a clinical trial. This role may encompass overseeing tasks across different regions, aiding in the management of Clinical Research Organizations (CROs), handling various third-party vendors, and supporting activities crucial to the study.
- Organizes project team meetings, distributes agendas, records, and finalizes meeting minutes, and compiles various presentations.
- Authors and edits study documents and plans, while keeping track of different versions.
- Reviews regulatory document packages from clinical sites for approving Investigational Medicinal Product release or initiating clinical trial activation, following relevant SOPs.
- Manages the Trial Master File (TMF) for assigned studies, with a deep understanding of set-up, maintenance, QC, and close-out processes. Also, mentors junior staff on ICH/GCP compliance and the importance of an inspection-ready TMF.
- Acts as a backup to the Clinical Trial Manager (CTM) when required.
- Reviews protocols, CRF data, lab data, tables/listings, study reports, and publications, identifying issues, proposing solutions, and providing data analysis in graphical formats as necessary.
- Acts as the primary contact between study site personnel, Contract Research Organizations (CRO), and other vendors to ensure studies progress as per agreed timelines and scope.
- Conducts monitoring report reviews, follows up on action items, and manages metrics for reports according to the study monitoring plan.
- Ensures data integrity at sites, including identifying and reporting deviations.
- Independently identifies areas requiring tracking of study-related activities or data, escalating site study risks and issues that may impact quality, safety, and/or timelines.
- Communicates with legal on contract/CDA negotiations with vendors and sites, maintains CMF forms, and tracks the status of such documents.
If you are having difficulty in applying or if you have any questions, please contact Roy Nelson at firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.