Sr. TMF Lead

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 (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 Alimentiv’s processes and systems across a program or product line.
• Monitor TMF health trends at the program level and escalate systemic issues with recommended solutions.
• Act as the primary TMF point of contact for sponsors and internal stakeholders at the program or product line level.

Mentorship & Staff Development (15–20%)

• Provide day-to-day guidance, coaching, and mentorship to TMF Associates and TMF Leads.
• Support onboarding and knowledge transfer for new TMF staff assigned to studies or programs.
• Contribute to performance feedback and development planning for junior TMF staff in collaboration with TMF management.
• Model TMF best practices and foster a culture of quality and compliance within the team.

Process, System & Continuous Improvement (10–15%)

• Contribute TMF subject matter expertise to the development, review, and improvement of TMF SOPs, work instructions, and tools.
• Identify and escalate TMF process gaps or systemic risks; propose and support implementation of solutions.
• Participate in TMF system enhancements, user acceptance testing, and cross-functional initiatives as a TMF SME.
• Support business development activities including RFP responses and sponsor due diligence as needed.

What you bring:

• Bachelor’s degree in life sciences, health sciences, information management, or a related field; or equivalent combination of education and experience.
• Minimum 5–7 years of direct TMF management experience in a CRO or pharmaceutical/biotech environment.
• Deep expertise in TMF Reference Model, ICH E6(R2/R3), and applicable regulatory requirements.
• Demonstrated experience managing TMF for complex, multi-regional clinical trials from start-up through close-out.
• Experience with eTMF systems (e.g., Veeva Vault, SharePoint-based systems, or similar platforms).
• Strong understanding of inspection readiness practices and experience supporting regulatory inspections or audits.
• Demonstrated ability to work independently, manage competing priorities, and exercise sound judgment.
• Strong communication and stakeholder management skills, with experience in sponsor-facing roles.
• Experience mentoring or providing guidance to junior team members.

Nice to have:

• Experience in GI/IBD therapeutic areas.
• Familiarity with Alimentiv’s service model or experience in a specialized CRO environment.
• Experience contributing to TMF process improvement initiatives or SOP development.

What we offer:

• Competitive compensation and benefits package.
• Opportunity to work with a purpose-driven, science-focused organization.
• Flexible, remote-first work environment.
• A collaborative team culture that values expertise and continuous learning.
• The chance to contribute to research that meaningfully impacts patients’ lives.