At a Glance
- Tasks: Lead TMF oversight for impactful studies, ensuring quality and compliance.
- Company: Join Alimentiv, a global CRO dedicated to advancing GI therapies.
- Benefits: Competitive salary, professional development, and a purpose-driven work environment.
- Other info: Dynamic team culture with opportunities for continuous improvement and mentorship.
- Why this job: Make a real difference in patients' lives while growing your career.
- Qualifications: 7-9 years in TMF with strong regulatory knowledge and leadership 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
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.
Sr. TMF Lead in Oxford employer: Alimentiv
At Alimentiv, we pride ourselves on being an exceptional employer that fosters a collaborative and innovative work culture. As a Senior TMF Lead, you will benefit from extensive professional development opportunities while working in a dynamic global environment that values your expertise and contributions. Our commitment to continuous improvement and employee well-being ensures that you will thrive both personally and professionally in this rewarding role.
StudySmarter Expert Advice🤫
We think this is how you could land Sr. TMF Lead in Oxford
✨Tip Number 1
Network like a pro! Reach out to people in the industry, especially those who work at Alimentiv or similar CROs. A friendly chat can open doors and give you insider info that could help you stand out.
✨Tip Number 2
Prepare for interviews by diving deep into TMF processes and the specific requirements of the role. Show us you know your stuff and can bring value to the team right from the get-go!
✨Tip Number 3
Don’t just wait for job postings! Keep an eye on our website and apply directly. It shows initiative and gives you a better chance of being noticed by our hiring team.
✨Tip Number 4
Follow up after interviews with a thank-you note. It’s a simple gesture that keeps you fresh in our minds and shows your enthusiasm for the role. We love a candidate who knows how to follow through!
We think you need these skills to ace Sr. TMF Lead in Oxford
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Sr. TMF Lead role. Highlight your relevant experience in TMF oversight and any specific projects that align with the job description. We want to see how your background fits our needs!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about advancing therapies for gastrointestinal diseases and how your skills can contribute to our mission at Alimentiv. Keep it engaging and personal!
Showcase Your Expertise:As a TMF subject matter expert, don’t shy away from showcasing your knowledge of ICH-GCP, risk-based TMF management, and inspection readiness. We’re looking for someone who can hit the ground running, so let us know what you bring to the table!
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way to ensure your application gets into the right hands. Plus, it shows us you’re serious about joining our team at Alimentiv!
How to prepare for a job interview at Alimentiv
✨Know Your TMF Inside Out
Make sure you have a solid understanding of the TMF processes and regulations, especially ICH-GCP and 21 CFR Part 11. Brush up on your knowledge of risk-based TMF management principles and be ready to discuss how you've applied these in past roles.
✨Showcase Your Leadership Skills
As a Sr. TMF Lead, you'll need to demonstrate your ability to lead teams and manage complex studies. Prepare examples of how you've successfully overseen TMF delivery and ensured compliance in previous positions. Highlight any mentoring or training you've provided to others.
✨Be Ready for Scenario Questions
Expect questions that assess your problem-solving skills in real-world TMF scenarios. Think about challenges you've faced in TMF oversight and how you resolved them. This will show your analytical skills and ability to think on your feet.
✨Align with Their Mission
Alimentiv is all about advancing therapies for gastrointestinal diseases. Familiarise yourself with their mission and values, and be prepared to discuss how your experience aligns with their goals. Show genuine interest in their work and how you can contribute to meaningful research.
