Senior Manager, Records Management

Position Summary: The Sr. Manager, Records Management will be responsible for oversight of all study level Trial Master Files including set-up, periodic and final QC and final transfer and archival. The position will develop oversight and TMF archival SOPs and manage the TMF archival platform. Job Duties and Responsibilities: Develop and implement a comprehensive records management strategy including oversight and archival SOPs and set-up and management of a TMF archival platform. Select and onboard/implement an archival TMF platform. Oversee the TMF archival process, ensuring that all documents are properly filed, indexed, and accessible. Ensure inspection readiness state for outsourced TMFs by conducting periodic quality control reviews and following up to ensure timely and appropriate resolution of findings. Prepare for and support health authority inspections (trial master file QCs, pulling documents during inspections). Stay current with regulatory requirements and industry best practices related to records management and TMF. Minimum Qualifications: Bachelor's degree in Life Sciences, Information Management, or a related field; advanced degree preferred. Minimum of 5-7 years of experience in records management within the pharmaceutical or biotech industry. Proven experience in setting up and managing TMF for clinical studies. Experience with implementing electronic records management systems and software. Demonstrated knowledge of regulatory requirements and industry best practices for records management in clinical research. Differentiating Qualifications: Experience in a startup environment is a plus. Skills and Knowledge Required: In-depth knowledge of records management principles and practices, particularly in the context of clinical trials and pharmaceutical research. Familiarity with regulatory requirements related to clinical documentation, including GCP, FDA, EMA and ICH guidelines. Strong organizational skills and attention to detail. Excellent communication and interpersonal skills. Ability to work collaboratively with cross-functional teams. Proficiency in electronic document management systems (EDMS) and other relevant software. Strong problem-solving skills and the ability to develop and implement effective solutions. Ability to manage multiple priorities and projects simultaneously.

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