Senior Trial Master File Specialist 1198706
Job Scope and Purpose:
Our Cambridge based biotech client is seeking a motivated Sr. TMF specialist to join their growing team. The incumbent will be responsible for supporting the set-up, maintenance, and archival of the study Trial Master File. Applicants should have prior experience with performing periodic study-level TMF quality, completeness, and timeliness reviews at defined timepoints to ensure adherence to TMF Specifications, ALCOA+ standard, company SOPs, ICH/Google Cloud Platform guidelines, Regulations, and industry best practices. If you consider yourself a TMF guru and want to join a fast-paced team with great leadership and great culture, continue reading and consider applying today.
Primary Job Requirements:
- Bachelor's Degree or its International Equivalent in Computer Science, Life Science, Health Science, or Information Management desirable but not mandatory.
- Minimum 5 years of pharmaceutical industry experience related to document management/TMF.
- Experience with Veeva Vault Clinical (eTMF) preferred.
- Experience working with the TMF Reference Model and ALCOA+ standard.
- Experience performing QC of TMF documents and CRO oversight QCs.
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
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