The Role
Provide expert, study-facing TMF oversight for complex studies and programs from start-up through close-out; ensure TMF quality, compliance, and inspection readiness using risk-based approaches and metrics; advise sponsors and stakeholders; lead audit/inspection activities; mentor TMF staff and drive process and system improvements.
Summary Generated by Built In
ABOUT ALIMENTIV
Alimentiv is a global CRO with a singular focus: advancing therapies for patients with gastrointestinal diseases. GI is our WHY and for more than 30 years that purpose has driven our scientific rigour, operational excellence, and deep therapeutic expertise, including supporting more than 70% of IBD compounds in development.
We operate as a private, profit-with-purpose company, channeling our commercial success back into scientific research, technology, and our people. With approximately 700 people across multiple countries and three service lines, we are growing deliberately, and the capability of our leaders and our organization is central to how we get there.
If you want to do meaningful work, build something real, and invest back in research that changes lives — we want to meet you.
THE OPPORTUNITYThe 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.
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:
- 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.
- 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.
- 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.
- 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.
Individual TMF Delivery (40–45%)
Program / Product Line TMF Oversight & Delivery (25–30%)
Study-Facing Process Alignment & Continuous Improvement (10–15%)
Training, Mentoring and Onboarding (10–15%)
About You:
- 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
certification) would be an asset - Continuous improvement mindset and ability to provide study-level process guidance
Education & Experience:
Skills Required
- 7-9 years recent TMF experience within a Contract Research Organization
- Honours Bachelor's degree or equivalent combination of education and experience
- Strong working knowledge of ICH-GCP, 21 CFR Part 11, EU CTR and other global regulatory requirements
- Knowledge of TMF Reference Model and risk-based TMF management principles
- Experience with inspection readiness activities (FDA, EMA, MHRA) and TMF audits
- Experience performing 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 experience
- Program-level or portfolio TMF oversight experience including study alignment and risk management
- Ability to advise sponsors and cross-functional stakeholders on TMF strategy and risk management
- Strong organizational, analytical, problem-solving, stakeholder management, communication and client-facing skills
- Ability to work effectively in a global, matrixed environment
- Certifications related to clinical research, quality, or regulatory compliance (SOCRA, ACRP, RAPS, TMF certification)
- Continuous improvement mindset and ability to provide study-level process guidance
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The Company
What We Do
From 1986 to 2020 we operated as Robarts Clinical Trials and built a strong foundation in the medical research community. In 2020, we became Alimentiv but retained our commitment to clinical trials, medical imaging, and precision medicine for GI-related ailments.
