Stratacuity: Proven Scientific Placement
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. 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.
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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. 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.
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