Our Cambridge based client is seeking a detail-oriented TMF Manager to ensure our Trial Master Files (TMFs) are inspection-ready and aligned with ICH GCP and GDP standards. You’ll support internal teams and CROs in maintaining high-quality documentation across clinical studies.

Key Responsibilities:

• Manage clinical document quality, control, and review
• Oversee internal eTMF systems and support CRO eTMF platforms
• Lead vendor interactions and provide eTMF training
• Maintain SOPs, filing guides, and documentation standards
• Collaborate cross-functionally to drive process improvements

Qualifications:

• Bachelor’s degree in a science or health-related field
• 5+ years of eTMF experience in pharma, biotech, or CRO
• Deep knowledge of TMF Reference Model and clinical documentation standards
• Experience with eTMF systems, SOP development, and vendor oversight
• Strong communication, training, and cross-functional collaboration skills
• This is a great opportunity for a self-starter who thrives in a fast-paced environment and is passionate about clinical documentation excellence.

About Stratacuity:

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.

PROVEN SCIENTIFIC PLACEMENT™

Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at [email protected] or 844-463-6178.