Original listing text, shown exactly as published by the company.
THE OPPORTUNITY
The Sr. TMF Lead provides expert, study-facing TMF oversight for assigned studies and complex programs, ensuring TMF
quality, compliance, and continuous inspection readiness. Acting as a TMF subject matter expert (SME), the role aligns
sponsor-specific TMF requirements with CRO processes, applies risk-based TMF management practices, and leads TMF
execution from study start-up through close-out. The Sr. TMF Lead independently advises sponsors and internal stakeholders,
mentors TMF staff, and contributes subject matter expertise to TMF process and system improvements.
Positions available: 1; this opportunity is cross-listed in multiple locations. At this time, the position is open to those residing in Germany, Brazil, Poland, Hungary, and Romania.
Closing date: June 12th, 2026, or until successful candidate identified.
The role
Individual TMF Delivery (40–45%)
- Serve as TMF Lead for complex, high-risk, or strategically important studies or programs.
- Provide end-to-end TMF oversight from study start-up through close-out, transfer, and archival.
- Utilize TMF metrics, KPIs, and risk-based assessments to monitor TMF health and inspection readiness.
- Partner with Project Management and Functional Leads to proactively manage TMF deliverables and risks.
- Ensure TMF oversight reports and status updates are delivered to sponsors and internal stakeholders on a defined
cadence.
- Lead study-level audit and inspection readiness activities and support audit responses.
Program / Product Line TMF Oversight & Delivery (25–30%)
- Provide strategic, study-facing oversight across assigned studies, programs, or product lines to ensure consistent
TMF execution.
- Align sponsor-specific TMF requirements with CRO processes and filing models, ensuring clear expectations for
study teams.
- Utilize TMF metrics, KPIs, and risk-based assessments to ensure TMFs meet standards for quality, completeness,
timeliness, and inspection readiness.
- Identify cross-study or systemic trends and risks; develop and drive mitigation strategies, corrective actions, and
targeted training initiatives.
- Act as TMF SME for TMF Management Plans, file and guidance.
- Support sponsor-facing TMF strategy discussions and governance forums.
- Act as escalation point for complex TMF risks and compliance issues.
Study-Facing Process Alignment & Continuous Improvement (10–15%)
- Ensure consistent application of TMF processes, standards, and quality expectations across assigned studies.
- Identify study-facing process gaps, inefficiencies, or compliance risks and escalate recommendations to TMF
Operations (TMFO) and Quality.
- Contribute subject matter expertise to TMF process updates, SOP revisions, and system enhancements led by
TMFO.
- Support implementation of updated TMF processes, tools, and system changes within study teams.
Training, Mentoring and Onboarding (10–15%)
- Provide advanced mentoring and TMF oversight guidance to TMF Leads, TMFAs, and TMFCs to ensure consistent
application of TMF standards.
- Develop and deliver advanced TMF training materials for study teams and functional stakeholders.
- Partner with Quality Training & Compliance (QTC) to ensure training reflects current processes and inspection
expectations.
- Serve as a knowledge resource for complex TMF scenarios, regulatory expectations, and inspection readiness.
About You
Education & Experience
- Minimum 7-9 years of recent, related experience in TMF function within a Contract Research Organization, along with an Honour's Bachelor's degree
- Equivalent combination of education and experience may be considered.
- Strong working knowledge of ICH-GCP, 21 CFR Part 11, EU CTR, and other global regulatory requirements
- TMF Reference Model and risk-based TMF management principles
- Experience with inspection readiness activities (FDA, EMA, MHRA, etc) and TMF audits
- Procedural gap analysis and issue resolution in TMF contexts
- Experience with leading eTMF platforms (e.g., Veeva Vault, Wingspan)
- TMF governance, quality oversight, and inspection readiness
- Strong organizational, analytical, and problem-solving skills
- Excellent stakeholder management, communication, and client-facing skills
- Ability to work effectively in a global, matrixed environment
- Program-level or portfolio TMF oversight experience, including study alignment and risk management within a
sponsor or CRO environment
- Demonstrated ability to advise sponsors and cross-functional stakeholders on TMF strategy and risk management
- Certifications related to clinical research, quality, or regulatory compliance (e.g., SOCRA, ACRP, RAPS, TMF…
