Senior Manager, TMF and Inspection Readiness Expert
1 day ago
Dyne Therapeutics is seeking a highly skilled Senior Manager, TMF and Inspection Readiness to join our clinical operations team. This role will play a critical part in ensuring the quality and integrity of our Trial Master File (TMF) and inspection readiness across all clinical trials.
Key Responsibilities- Manage TMF files, including upload, review, and approval of documents, to ensure compliance with ICH-GCP guidelines and internal SOPs.
- Develop and implement processes and strategies to ensure inspection readiness, including management of clinical operations storyboards and coordination of inspection readiness activities.
- Collaborate with clinical operations teams to develop and maintain TMF documents, such as the TMF Plan, Index, and SOPs.
- Ensure quality management of studies by reporting TMF metrics, conducting periodic checks of adherence to SOPs, and reconciling outstanding queries and issues.
- Oversee the activities of external vendors to ensure compliance with ICH-GCP guidelines, regulatory requirements, and internal SOPs.
- 7+ years of relevant clinical operations and TMF experience in the biotechnology, pharmaceutical, or TMF vendor industry.
- 4+ years of experience working in eTMF system software, with a preference for Veeva Vault eTMF system software.
- Strong knowledge of the clinical trial lifecycle, including understanding of the Trial Master File Reference Model Structure standard and country-level documents.
- Experience with global agency inspections and demonstrated ability to understand and comply with ALCOA+ standards, ICH-GCP guidelines, and Good Documentation Practices.
- Excellent communication and organizational skills, with the ability to work independently and as part of a team.
Dyne Therapeutics is a clinical-stage muscle disease company focused on advancing innovative life-transforming therapeutics for people living with genetically driven diseases. Our proprietary FORCETM platform enables the development of modern oligonucleotide therapeutics designed to overcome limitations in delivery to muscle tissue.
We are committed to fostering a culture of innovation, collaboration, and excellence, and we are seeking talented individuals who share our passion for making a difference in the lives of patients.
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