TMF Operations Specialist

Experteer Overview In this role you will oversee the end-to-end TMF lifecycle for clinical trials, ensuring regulatory compliance and alignment with internal standards. You will lead the TMF Plan and Index, drive inspection readiness, and coordinate TMF activities across CROs and study teams. The role supports broader R&D Operations, including vendor contracts, while exploring AI-enabled improvements to boost quality and efficiency.

You will work closely with cross‑functional groups to maintain robust documentation and enable seamless study execution.

Retribuzione / Benefits Oversee TMF setup, maintenance, and archiving for clinical trials

Ensure TMF is inspection‑ready and compliant with ICH GCP and SOPsApply risk‑based TMF management, prioritizing critical documents

Manage electronic and paper TMFs where applicable

Ensure records are captured and archived per the TMF Index Provide guidance on ISF documentation

Ensure external provider documents are included in the TMF Index and archived

Conduct TMF quality checks and internal audits

Monitor CRO KPIs related to TMF quality and timeliness

Support inspections and new acquisitions through TMF/documentation quality checks

Oversee CRO performance related to TMF activities and adherence to timelines

Support TMF migrations from external partners with mapping and compliance during transfer

Integrate TMF with other study systems and tools

Create and maintain the TMF Plan and TMF Index Monitor TMF system active users and access control

Generate TMF status reports for management

Provide TMF training and cross‑functional support

Collaborate with study start‑up, CSTs, CRAs, and other teams on timely documentation

Coordinate study contracts and vendor invoicing against milestones

Responsabilità3-5 years of TMF management experience in pharma/CROStrong understanding of ICH‑GCP and regulatory requirements

Proficiency in TMF management systems (Veeva) and MS Office Excellent organizational and communication skills

Attention to detail and problem‑solving abilities

Strong documentation and audit readiness mindset
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