Sr. TMF Lead - #2628233

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 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. 

• 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

• 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

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.