At a Glance
- Tasks: Lead TMF oversight for complex studies, ensuring quality and compliance throughout the process.
- Company: Alimentiv, a global CRO dedicated to advancing GI therapies with a purpose-driven approach.
- Benefits: Competitive salary, opportunities for professional growth, and a chance to make a real impact.
- Other info: Work in a dynamic, global environment with opportunities for mentorship and career advancement.
- Why this job: Join a mission-driven team focused on improving lives through innovative research in gastrointestinal diseases.
- Qualifications: 7-9 years of TMF experience, strong knowledge of regulatory requirements, and excellent communication skills.
The predicted salary is between 60000 - 80000 £ per year.
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 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 elevate recommendations to 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 certification) would be an asset
- Continuous improvement mindset and ability to provide study‑level process guidance
Sr. TMF Lead in Cambridge employer: Alimentiv
At Alimentiv, we pride ourselves on being a purpose-driven employer dedicated to advancing therapies for gastrointestinal diseases. Our collaborative work culture fosters innovation and continuous learning, providing employees with ample opportunities for professional growth while contributing to meaningful research that impacts lives. With a commitment to scientific excellence and a supportive environment, we ensure our team members thrive both personally and professionally in locations across Europe and beyond.
StudySmarter Expert Advice🤫
We think this is how you could land Sr. TMF Lead in Cambridge
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like Alimentiv.
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If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like Alimentiv. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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We think you need these skills to ace Sr. TMF Lead in Cambridge
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Alimentiv!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Alimentiv that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Alimentiv!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Alimentiv, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Alimentiv
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Alimentiv that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Alimentiv’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
