Sr. TMF Lead

Alimentiv

Job Location:

Belfast - UK

Monthly Salary: Not Disclosed

Posted on: 9 days ago

Vacancies: 1 Vacancy

Job Summary

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 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 (4045%)

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 (2530%)

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 (1015%)

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 (1015%)

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 Honours Bachelors 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

43000 - 73500 a year

Bonus

Please note that the above range reflects the full spectrum of compensation for candidates located in the UK our Talent Acquisition team will be happy to discuss specific local compensation at time of interview.

We may use artificial intelligence (AI) tools to support parts of the hiring process such as reviewing applications analyzing resumes or assessing responses. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed please contact us.

Required Experience:

Senior IC

ABOUT ALIMENTIVAlimentiv 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...