At a Glance
- Tasks: Lead TMF oversight for complex studies, ensuring quality and compliance.
- Company: Join Alimentiv, a global CRO dedicated to advancing GI therapies.
- Benefits: Competitive salary, bonus potential, and opportunities for professional growth.
- Other info: Flexible work locations across Europe with a focus on continuous improvement.
- Why this job: Make a real impact in healthcare while working with a passionate team.
- Qualifications: 7-9 years in TMF, strong knowledge of regulatory requirements, and excellent communication skills.
The predicted salary is between 43000 - 73500 £ per year.
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.
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 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 (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.
£43,000 - £73,500 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 the 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.
Sr. TMF Lead in Belfast 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 patients' 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.
StudySmarter Expert Advice🤫
We think this is how you could land Sr. TMF Lead in Belfast
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry, attend relevant events, and engage with professionals on platforms like LinkedIn. We all know that sometimes it’s not just what you know, but who you know that can help you land that dream job.
✨Tip Number 2
Prepare for interviews by researching the company and its culture. Understand their mission, especially how they focus on advancing therapies for gastrointestinal diseases. We want you to show genuine interest and align your values with theirs during the conversation.
✨Tip Number 3
Practice common interview questions and tailor your answers to highlight your TMF expertise. We suggest using the STAR method (Situation, Task, Action, Result) to structure your responses. This will help you articulate your experience clearly and effectively.
✨Tip Number 4
Don’t forget to follow up after your interview! A simple thank-you email can go a long way in leaving a positive impression. We recommend mentioning something specific from your conversation to remind them of your fit for the role.
We think you need these skills to ace Sr. TMF Lead in Belfast
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 with our mission at Alimentiv!
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 goals. Keep it engaging and personal, so we get a sense of who you are.
Showcase Your Expertise:As a TMF subject matter expert, make sure to highlight your knowledge of ICH-GCP, risk-based TMF management, and inspection readiness activities. We’re looking for someone who can bring their expertise to the table and help us improve our processes.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows 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 mentor and guide others. Prepare examples of how you've successfully led teams or projects, particularly in high-risk or complex studies. Highlight your experience in training and developing TMF staff.
✨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 previous roles, how you identified gaps, and the strategies you implemented to resolve them. This will show your analytical and critical thinking abilities.
✨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 personal goals align with theirs. Showing genuine interest in their work can set you apart from other candidates.
