TMF Manager - Contract - Cambridge, MA
Are you ready to shape the future of healthcare by overseeing important TMF data in a company where science meets purpose?
Proclinical is seeking an e-TMF Specialist to support clinical trial documentation processes.
Primary Responsibilities:
In this role, you will ensure Trial Master Files (TMFs) are current, accurate, and inspection-ready for internal and external audits. You will collaborate with cross-functional teams, oversee e-TMF systems, and provide guidance on best practices for document management. This position is ideal for someone with a strong understanding of clinical trial conduct, TMF structure, and e-TMF systems.
Skills & Requirements:
- Strong knowledge of TMF Reference Model and its application in clinical trials.
- Familiarity with ICH Good Clinical Practice (GCP) and Good Documentation Practice (GDP) principles.
- Experience with e-TMF systems, including system setup, user training, and validation processes.
- Ability to manage multiple e-TMF vendors and collaborate effectively with CRO partners.
- Proficiency in identifying and implementing e-TMF filing requirements across various functional areas.
- Excellent organizational and communication skills to train and guide internal and external stakeholders.
- Bachelor's degree in a science or health-related field, or equivalent combination of education and experience.
The TMF Manager's responsibilities will be:
- Manage the quality control and maintenance of Trial Master Files (TMFs).
- Oversee the setup and ongoing management of internal e-TMF applications.
- Support Clinical Operations Study Leaders in the quality control and oversight of CRO-managed e-TMF systems.
- Act as the functional lead for specified e-TMF platforms in collaboration with vendors.
- Provide training and guidance to e-TMF users, including external partners such as CROs.
- Ensure timely and accurate e-TMF filing and maintenance in compliance with ICH GCP guidelines.
- Collaborate with management to develop and implement new procedures and advocate for process improvements.
- Contribute to the development and review of standard operating procedures (SOPs) and work instructions related to clinical document management.
- Maintain and update Naming and Filing Guides for relevant e-TMF systems.
- Partner with cross-functional teams to ensure alignment on e-TMF processes and documentation standards.
- Support organizational initiatives aimed at enhancing clinical document management practices.
Compensation:
If you are having difficulty in applying or if you have any questions, please contact Shannon Briggs at s.briggs@proclinical.com
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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