At a Glance
- Tasks: Support and analyse the Trial Master File (TMF) to ensure inspection readiness.
- Company: Join Cencora, a leader in clinical operations with a commitment to excellence.
- Benefits: Competitive salary, flexible working options, and opportunities for professional growth.
- Other info: Collaborative team culture with a focus on innovation and career advancement.
- Why this job: Make a real impact in clinical trials while developing your skills in a dynamic environment.
- Qualifications: Degree-level education preferred; 2 years of relevant experience in Clinical or TMF Operations.
The predicted salary is between 30000 - 40000 £ per year.
The TMF Study Administrator provides expert support and analysis of the TMF, based on established procedures, to help maintain the inspection readiness of our clients’ Trial Master File (TMF). They are key members of the team, promoting TMF health and best practices, while supporting senior members of the team with completing assigned tasks.
Responsibilities
- Manage paper documents (including filing and/or shipping) as required.
- Process, upload, and index TMF documents.
- Track and maintain TMF documentation.
- Perform in‑line document quality control.
- Support TMF set‑up based on pre‑defined structure and confirmed study requirements.
- Amend the study‑specific TMF structure in line with confirmed study events and changes.
- Support creation of the study‑specific TMF Index or equivalent.
- Run metrics reports, communicating output.
- Identify and share high‑level trends in metrics reports.
- Perform TMF quality review (QR).
- Communicate QR findings and identify high‑level trends.
- Conduct risk‑based TMF analysis (e.g., heatmaps) if required.
- Support remediation projects, including query management and remediation tasks.
- Support retrospective TMF reconciliation projects, performing assigned tasks.
- Understand and utilize appropriate escalation pathways.
- Communicate with the study team on TMF‑related matters.
Education
- Degree‑level education preferred; equivalent work experience in a relevant field considered.
Experience
- 2 years of relevant industry experience in Clinical or TMF Operations oversight.
- Excellent knowledge of document recognition and Good Documentation Practices (GDP).
- Working knowledge of eTMF system.
Familiar With
- Clinical Trial Lifecycle.
- TMF Reference Model (or equivalent).
- Referencing and applying applicable resources.
- TMF Health & Metrics.
- TMF Quality Review Process.
- Internal communication and escalation pathways.
Aware Of
- TMF Lifecycle.
- Other clinical/document management systems.
- TMF Stakeholders.
- TMF set‑up process.
- TMF Management Plans.
- TMF Training.
- Inspection Readiness.
- External communication and escalation pathways.
Independent In
- Verbal and written communication.
- Interpersonal interactions.
- Organization and external collaboration.
- Negotiation and conflict resolution.
- Working under pressure.
- Information analysis.
What Cencora Offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. Eligibility and effective dates may differ for some benefits and for team members covered under collective bargaining agreements.
Equal Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state or local law. Harassment is prohibited, and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non‑discriminatory. Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call or email.
TMF Study Administrator in London employer: Cencora
Cencora is an exceptional employer that prioritises employee growth and development, offering a collaborative work culture where team members are encouraged to share insights and best practices in TMF management. With a commitment to equal opportunity and a supportive environment, employees can thrive in their roles while contributing to the health of our clients' Trial Master Files. Located in a dynamic industry, Cencora provides unique opportunities for professional advancement and meaningful contributions to clinical operations.
StudySmarter Expert Advice🤫
We think this is how you could land TMF Study Administrator in London
✨Tip Number 1
Network like a pro! Reach out to your connections in the clinical trial space and let them know you're on the lookout for TMF Study Administrator roles. You never know who might have the inside scoop on an opening!
✨Tip Number 2
Prepare for interviews by brushing up on your TMF knowledge. Familiarise yourself with the TMF lifecycle and metrics reports, so you can confidently discuss how you can contribute to maintaining inspection readiness.
✨Tip Number 3
Don’t just apply anywhere—apply through our website! We love seeing applications from motivated candidates who are genuinely interested in joining our team at StudySmarter.
✨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in showing your enthusiasm for the role and keeping you top of mind for the hiring team.
We think you need these skills to ace TMF Study Administrator in London
Some tips for your application 🫡
Tailor Your CV:Make sure your CV highlights relevant experience in TMF operations and document management. We want to see how your skills align with the responsibilities listed in the job description, so don’t hold back!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you’re passionate about TMF health and how your background makes you a perfect fit for our team. Keep it concise but impactful.
Showcase Your Attention to Detail:Since the role involves document quality control and metrics reporting, make sure your application is free from typos and errors. We appreciate candidates who demonstrate precision right from the start!
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’s super easy!
How to prepare for a job interview at Cencora
✨Know Your TMF Inside Out
Before the interview, make sure you brush up on your knowledge of the Trial Master File (TMF) and its lifecycle. Familiarise yourself with key concepts like document quality control and TMF health metrics. This will show that you're not just interested in the role but also understand the intricacies involved.
✨Prepare for Practical Scenarios
Expect to be asked about real-life scenarios related to TMF management. Think of examples from your past experience where you successfully managed documents or improved processes. Be ready to discuss how you would handle specific challenges, such as risk-based TMF analysis or query management.
✨Showcase Your Communication Skills
Since the role involves a lot of communication with study teams and stakeholders, practice articulating your thoughts clearly. Prepare to discuss how you've effectively communicated findings or collaborated with others in previous roles. Highlight any experience you have with internal and external communication pathways.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions! Inquire about the team dynamics, ongoing projects, or how they measure TMF success. This not only shows your interest in the position but also helps you gauge if the company culture aligns with your values.
