TMF Oversight Lead

Opportunity Details

On Assignment TMF Oversight Lead

Remote USA

Primary Responsibilities

• Conduct TMF Process Oversight, ensuring study documents are uploaded, indexed, and classified per the TMF Plan and Essential Document List (EDL).
• Maintain/update sponsor TMF tools/templates, including TMF Plan, TMF Index, TMF Business Rules;
• Provide TMF SME support to study teams with preparation of study specific TMF Index and setup of Essential Document List (EDL) and study IR milestones in Veeva.
• Track essential documents against the EDL, identifying gaps and ensuring timely collection and filing.
• Escalate missing, incomplete of non-compliant documents to study teams and facilitate resolution. ensure unresolved TMF issues or persistent noncompliant issues are escalated to resolve critical gaps. Ensure that unresolved TMF issues or persistent non-compliance are further escalated to appropriate stakeholders to address and close critical gaps in a timely manner.
• Maintain up-to-date logs, checklists, trackers, and documentation related to the eTMF.
• Generate metrics and inventory reports with regards to TMF health/status including actionable metrics for projects/programs; Support a defined reporting cadence (e.g., monthly, quarterly) and take ownership of maintaining and updating TMF dashboards to ensure consistent visibility and oversight.
• Periodically perform and/or oversee TMF risk-based quality checks and reporting findings to the appropriate functional group or document owner to mitigate findings, to promote inspection readiness
• Resolve noncompliance with overdue quality check review findings
• Monitor and identify TMF trends and escalate concerns to leadership; use a TMF risk management framework to define and monitor TMF Trends (e.g., risk scoring, prioritization).
• Contribute to effective TMF processes, systems, and training by identifying continuous improvement opportunities and participating in and/or leading related projects
• Train and support study teams on eTMF processes, EDL requirements, and document management best practices; Support the development and delivery of formal TMF training programs, lessons learned or other platforms (Veeva Power Hour and others)
• Act as an SME for TMF/eTMF and provide guidance, support, and issue resolution to sponsor study team members and CSPs as needed; may provide process training as needed; engage with cross-functional stakeholders (e.g., Regulatory, QA, Clinical and other R&D functions, as needed).
• Lead and/or participate in other TMF related processes and/or projects as directed
• Support inspection readiness activities, including eTMF audits, mock inspections, and regulatory inspections; retrieve, prepare and provide eTMF documents for audits and inspections as requested; contribute to a structured process for capturing and applying lessons learned post-inspection or audit.
• Assist Inspection Readiness Leads with readiness planning and oversight of vendor performance.

Education and Experience:

• Bachelor’s degree with an emphasis on life sciences, or health related field from an accredited institution preferred OR an equivalent combination of education and applicable job experience may be considered.
• 6+ years’ experience in pharmaceutical industry and/or clinical research organization, with at least 4 years in a compliance, quality, clinical or TMF role.
• Extensive experience with eTMF systems (Veeva Clinical eTMF preferred).
• Demonstrates extensive experience in generating TMF metrics, managing eTMF dashboards, and utilizing Excel tools—including pivot tables—for data analysis, reporting, and visualization. TMF experience required, including experience performing quality and completeness reviews as well as defining and generating TMF KPIs/metrics.
• Knowledge of ICH-GCP, TMF Reference Model, and regulatory requirements for TMF documentation.