Manager, TMF Management & Oversight
Planet Pharma, New Haven, CT, United States
Job Description
Manager, TMF Management & Oversight
The Manager, Trial Master File (TMF) is a hands‑on TMF Subject Matter Expert (SME) responsible for executing, maintaining, and continuously improving the quality and compliance of the TMF across clinical studies. This role combines operational ownership with SME‑level expertise, ensuring a complete, accurate, and inspection‑ready TMF in alignment with ICH‑GCP and global regulatory requirements.
This position partners closely with Clinical Operations, Clinical Sub‑Team (CST) members, and external vendors, and serves as a primary driver of TMF quality, execution, and inspection readiness.
Key Responsibilities
Act as a hands‑on TMF SME, actively managing TMF activities across the study lifecycle (start‑up, maintenance, and closeout)
Execute and maintain end‑to‑end TMF oversight (internally and externally managed eTMF), ensuring quality and compliance—not just governance
Ensure TMF completeness, accuracy, and timeliness in accordance with ICH‑GCP, TMF Reference Model, and internal SOPs
Perform and lead ongoing TMF quality control (QC), quality review (QR), reconciliation, and completeness reviews
Drive TMF health metrics, identify gaps, and implement corrective and preventive actions (CAPAs)
Maintain continuous inspection readiness and actively support regulatory inspections and audits (preparation, conduct, and follow‑up)
Serve as eTMF system SME, including hands‑on support with configuration, taxonomy, metadata, and user adoption
Participate in system enhancements and releases (requirements, UAT scripting/testing, release reviews)
Author and maintain TMF documentation (e.g., TMF Management Plans, content lists, process documents, training materials)
Lead TMF reconciliation activities with internal teams, CROs, and vendors
Manage and oversee CRO/vendor TMF deliverables, ensuring adherence to standards and timelines
Drive continuous process improvement to enhance TMF quality, efficiency, and compliance
Support TMF migrations, system implementations, and vendor transitions
Act as the primary TMF point of contact for assigned studies
Provide hands‑on training, mentorship, and guidance to team members and study partners
Contribute to TMF standards, governance, and best practices, with a focus on execution and quality
Qualifications
5–8+ years of direct, hands‑on TMF/eTMF experience in clinical research (execution‑focused, not solely oversight)
Demonstrated expertise in TMF quality management, QC/QR, reconciliation, and inspection readiness
Strong knowledge of ICH‑GCP, TMF Reference Model, and global regulatory requirements
Hands‑on experience with eTMF systems (e.g., Veeva Vault TMF or equivalent), including metadata and document management practices
Proven ability to identify TMF gaps and drive resolution independently
Experience working with CROs and vendors on TMF deliverables and quality
Strong organizational skills with the ability to manage multiple studies in a fast‑paced environment
Effective cross‑functional collaboration and stakeholder influence
Excellent analytical, problem‑solving, and communication skills
Education
Bachelor’s degree in Life Sciences, Health Sciences, or related field required
Advanced degree preferred
Pay range: 40-51/hr *based on expereincce
#J-18808-Ljbffr
Manager, TMF Management & Oversight
The Manager, Trial Master File (TMF) is a hands‑on TMF Subject Matter Expert (SME) responsible for executing, maintaining, and continuously improving the quality and compliance of the TMF across clinical studies. This role combines operational ownership with SME‑level expertise, ensuring a complete, accurate, and inspection‑ready TMF in alignment with ICH‑GCP and global regulatory requirements.
This position partners closely with Clinical Operations, Clinical Sub‑Team (CST) members, and external vendors, and serves as a primary driver of TMF quality, execution, and inspection readiness.
Key Responsibilities
Act as a hands‑on TMF SME, actively managing TMF activities across the study lifecycle (start‑up, maintenance, and closeout)
Execute and maintain end‑to‑end TMF oversight (internally and externally managed eTMF), ensuring quality and compliance—not just governance
Ensure TMF completeness, accuracy, and timeliness in accordance with ICH‑GCP, TMF Reference Model, and internal SOPs
Perform and lead ongoing TMF quality control (QC), quality review (QR), reconciliation, and completeness reviews
Drive TMF health metrics, identify gaps, and implement corrective and preventive actions (CAPAs)
Maintain continuous inspection readiness and actively support regulatory inspections and audits (preparation, conduct, and follow‑up)
Serve as eTMF system SME, including hands‑on support with configuration, taxonomy, metadata, and user adoption
Participate in system enhancements and releases (requirements, UAT scripting/testing, release reviews)
Author and maintain TMF documentation (e.g., TMF Management Plans, content lists, process documents, training materials)
Lead TMF reconciliation activities with internal teams, CROs, and vendors
Manage and oversee CRO/vendor TMF deliverables, ensuring adherence to standards and timelines
Drive continuous process improvement to enhance TMF quality, efficiency, and compliance
Support TMF migrations, system implementations, and vendor transitions
Act as the primary TMF point of contact for assigned studies
Provide hands‑on training, mentorship, and guidance to team members and study partners
Contribute to TMF standards, governance, and best practices, with a focus on execution and quality
Qualifications
5–8+ years of direct, hands‑on TMF/eTMF experience in clinical research (execution‑focused, not solely oversight)
Demonstrated expertise in TMF quality management, QC/QR, reconciliation, and inspection readiness
Strong knowledge of ICH‑GCP, TMF Reference Model, and global regulatory requirements
Hands‑on experience with eTMF systems (e.g., Veeva Vault TMF or equivalent), including metadata and document management practices
Proven ability to identify TMF gaps and drive resolution independently
Experience working with CROs and vendors on TMF deliverables and quality
Strong organizational skills with the ability to manage multiple studies in a fast‑paced environment
Effective cross‑functional collaboration and stakeholder influence
Excellent analytical, problem‑solving, and communication skills
Education
Bachelor’s degree in Life Sciences, Health Sciences, or related field required
Advanced degree preferred
Pay range: 40-51/hr *based on expereincce
#J-18808-Ljbffr