Proclinical is partnered with a biotech company seeking a TMF Manager for a contract role in Cambridge, MA.
Primary Responsibilities:
The successful candidate will maintain Trial Master Files (TMFs) to ensure they are current and inspection ready. They will need a strong understanding of clinical trial conduct, TMF structure, eTMF systems, and best documentation practices.
Skills & Requirements:
Bachelor's degree or equivalent combination of education/experience in science or health-related field.
Experience with e/TMF systems for a pharmaceutical, biotechnology company, or contract research organization.
Thorough knowledge of the DIA Reference Model and e/TMF filing requirements.
Understanding of ICH GCP and Good Documentation Practice (GDP) principles.
Experience with eTMF system or software, including SOP development, user training, and performing UATs and validations.
Ability to prioritize tasks based on project goals.
Strong interpersonal and organizational skills with attention to detail.
Excellent communication and public speaking skills.
Ability to engage in cross-functional interactions with internal and external staff.
Global trial experience is a plus.
The TMF Manager's responsibilities will be:
Manage clinical document quality, control, and filing, including TMFs.
Perform setup activities, document filing, and oversight of internal e/TMF applications.
Support Clinical Operations Study Leaders in the QC and oversight of CROs' e/TMF applications.
Act as the functional lead for specified e/TMF platforms with vendors.
Provide support and guidance to CROs and support staff to ensure accurate and timely eTMF filing and maintenance according to ICH GCP guidelines.
Provide training to eTMF users and external parties (CROs).
Partner with management and others to support functional and organizational initiatives.
Support the development and review of standard operating procedures and work instructions related to clinical document management.
Create and maintain written instructions, SOPs, guidelines, and plans related to e/TMFs and document control.
Update and maintain Naming and Filing Guides for relevant e/TMF systems.
Collaborate with all applicable functional areas.
Work with Clinical Operations Management to drive new procedures and processes within the department.
If you are having difficulty in applying or if you have any questions, please contact Parker Jensen at p.jensen@proclinical.com
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.