Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Join us as a TMF Study Owner, managing study-specific TMF structures and ensuring compliance.
- Company: Cencora is dedicated to creating healthier futures for people and animals through innovative pharma consulting.
- Benefits: Enjoy flexible work options, competitive perks, and a supportive team environment.
- Why this job: Make a real impact in health while collaborating with passionate professionals in a dynamic culture.
- Qualifications: 5 years of experience in Clinical or TMF Operations with strong documentation skills required.
- Other info: Opportunity to lead training sessions and enhance your career in a global company.
The predicted salary is between 36000 - 60000 £ per year.
Social network you want to login/join with:
Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
This role is in support of Cencora\’s global pharma consulting services marketed through our PharmaLex business.
AS TMF Study Owner you will be responsible for supporting the setup of the study-specific TMF structure, liaising with the Study Team to establish requirements, monitoring milestones and events to ensure TMF Completeness via eTMF functionality.
Responsibilities:
Remain Familiar with relevant SOPs and processes to be able to support and signpost study team to relevant guidance.
Monitor study events and ad hoc changes, ensuring updates to the study-specific TMF structure are implemented.
Write/initiate creation of the study-specific TMF Management Plan in collaboration with Study Team.
Support study team through closeout and archive preparations.
Ensure ongoing adherence to TMF SOPs and specifications.
Perform and/or support Quality Review and perform spot-checks for quality oversight.
Provide TMF Health status updates and review metric reports outputs on a recurring basis, with guidance on improving and maintaining.
Help facilitate, track, and support periodic Study Team TMF Reviews.
Perform a deep-dive of report outputs; identify and share trends and risk areas with Study Teams.
Manage remediation and reconciliation projects.
Support implementation of CAPAs at study level.
Identify and escalate risk and trends impacting Inspection Readiness.
Facilitate TMF-focussed communication and collaboration between Sponsor and CROs.
Act as TMF SME, including related processes, to provide ongoing support to Study Team.
Provide feedback to support development of internal and/or external TMF-related trainings.
Conduct training for Study Team and/or colleagues, either 121 or in group setting.
.
Requirements:
5 years relevant industry experience in Clinical or TMF Operations oversight.
Excellent knowledge of Good Documentation Practices and document recognition
Good knowledge of referencing/applying applicable resources
Working knowledge of: clinical trial lifecycle, TMF Reference Model (or equivalent), eTMF systems, TMF Health & Metrics, including Quality Review process
Internal communication/escalation pathways
Familiar with: TMF lifecycle, other clinical/document management systems, TMF stakeholders, TMF set-up process and Management Plans, TMF training, Inspection Readiness
Skills:
Experienced in coaching and mentoring
Excellent presentation skills
Experienced in negotiation and conflict resolution
Working under pressure
What Cencora offers
Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.
Full time #J-18808-Ljbffr
TMF Study Owner employer: Cencora
Contact Detail:
Cencora Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land TMF Study Owner
✨Tip Number 1
Familiarise yourself with the TMF Reference Model and eTMF systems. Understanding these frameworks will not only help you in your role but also demonstrate your commitment to the position during interviews.
✨Tip Number 2
Network with professionals in the clinical trial and TMF operations field. Attend relevant industry events or join online forums to connect with others who can provide insights and potentially refer you to opportunities at Cencora.
✨Tip Number 3
Prepare to discuss your experience with Quality Review processes and how you've managed TMF completeness in past roles. Be ready to share specific examples that highlight your problem-solving skills and attention to detail.
✨Tip Number 4
Showcase your coaching and mentoring abilities. Think of instances where you've trained colleagues or improved team performance, as this aligns well with the responsibilities of a TMF Study Owner at Cencora.
We think you need these skills to ace TMF Study Owner
Some tips for your application 🫡
Understand the Role: Before applying, make sure you fully understand the responsibilities of a TMF Study Owner. Familiarise yourself with the key tasks mentioned in the job description, such as supporting the TMF structure and monitoring milestones.
Tailor Your CV: Highlight your relevant experience in Clinical or TMF Operations oversight. Make sure to include specific examples that demonstrate your knowledge of Good Documentation Practices and your familiarity with eTMF systems.
Craft a Compelling Cover Letter: Use your cover letter to express your passion for improving health outcomes and how your skills align with Cencora's mission. Mention your experience in coaching and mentoring, as well as your ability to work under pressure.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors. Ensure that your application is clear, concise, and free from typos, as attention to detail is crucial in this role.
How to prepare for a job interview at Cencora
✨Know Your TMF Basics
Make sure you have a solid understanding of the TMF lifecycle and the TMF Reference Model. Familiarise yourself with Good Documentation Practices and be ready to discuss how these apply to your previous experiences.
✨Showcase Your Communication Skills
As a TMF Study Owner, you'll need to facilitate communication between various stakeholders. Prepare examples of how you've successfully communicated complex information in the past, especially in high-pressure situations.
✨Demonstrate Problem-Solving Abilities
Be ready to discuss specific instances where you've identified risks or trends in TMF processes and how you addressed them. Highlight your experience with CAPAs and how you've implemented solutions effectively.
✨Prepare for Scenario-Based Questions
Expect questions that assess your ability to handle real-life scenarios related to TMF management. Think about challenges you've faced in previous roles and how you overcame them, particularly in relation to study closeout and archive preparations.
