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- Tasks: Lead TMF management, ensuring accuracy and readiness for inspections.
- Company: Join a leading organisation in clinical trial management.
- Benefits: Competitive salary, flexible working options, and professional growth opportunities.
- Why this job: Be the key contact in a vital role that impacts clinical trials.
- Qualifications: 5+ years in TMF management with strong documentation skills.
- Other info: Dynamic team environment with a focus on innovation and improvement.
The predicted salary is between 48000 - 72000 £ per year.
Overview
The TMF Program Lead acts as the key customer contact and subject matter expert, responsible for overseeing Study Resources and ensuring complete and accurate study Trial Master Files (TMFs). They promote inspection readiness, conduct trend analysis of TMF metrics, and establish proactive partnerships with customers and study teams.
Responsibilities
- TMF Management: Oversee TMF management, identify improvement strategies, and share best practices.
- TMF Metrics: Review portfolio metrics, analyze trends, and recommend improvements.
- TMF Health: Monitor TMF health at portfolio and vendor levels, gather customer feedback, and provide guidance based on risk analysis.
- Inspection Readiness: Establish oversight practices, support audits and inspections, and implement CAPAs.
- Customer Relationships: Maintain relationships with Study Management and Leadership, and communicate trends and issues.
- Team Management: Manage workload, oversee KPIs, support recruitment, and develop team training programs.
Qualifications
- Minimum 5 years in a TMF Study Owner or equivalent role.
- Good Documentation Practices (GDP)
- TMF Reference Model or equivalent
- Experience with eTMF systems and clinical trial lifecycle management
- Knowledge of TMF stakeholders, processes, and inspection readiness
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TMF Program Lead employer: Cencora, Inc.
Contact Detail:
Cencora, Inc. Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land TMF Program Lead
✨Tip Number 1
Network like a pro! Reach out to your connections in the industry and let them know you're on the lookout for TMF Program Lead roles. You never know who might have the inside scoop on an opportunity that’s not even advertised yet.
✨Tip Number 2
Prepare for interviews by brushing up on your TMF knowledge and metrics analysis. Be ready to discuss how you've improved TMF health in past roles and share specific examples of your success in maintaining inspection readiness.
✨Tip Number 3
Showcase your customer relationship skills! During interviews, highlight how you've built proactive partnerships with study teams and customers. This is key for a TMF Program Lead, so make sure they see you as a team player.
✨Tip Number 4
Don’t forget to apply through our website! We’ve got loads of resources to help you land that TMF Program Lead position. Plus, it shows you’re serious about joining our team and makes it easier for us to find your application.
We think you need these skills to ace TMF Program Lead
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the TMF Program Lead role. Highlight your experience with TMF management and any relevant metrics you've worked with. We want to see how your background aligns with our needs!
Showcase Your Skills: In your cover letter, don’t just list your qualifications—show us how you’ve used them in real situations. Talk about your experience with eTMF systems and how you’ve ensured inspection readiness in past roles.
Be Clear and Concise: When writing your application, keep it clear and to the point. Use bullet points for key achievements and avoid jargon unless it’s relevant to the TMF field. We appreciate straightforward communication!
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 TMF Program Lead position. Don’t miss out!
How to prepare for a job interview at Cencora, Inc.
✨Know Your TMF Inside Out
Make sure you’re well-versed in the Trial Master File (TMF) processes and best practices. Brush up on your knowledge of eTMF systems and the clinical trial lifecycle, as this will show your expertise and confidence during the interview.
✨Showcase Your Analytical Skills
Be prepared to discuss how you've previously analysed TMF metrics and identified trends. Bring examples of improvement strategies you've implemented in past roles, as this will demonstrate your proactive approach and problem-solving abilities.
✨Emphasise Relationship Building
Since maintaining customer relationships is key, think of specific instances where you’ve successfully collaborated with study teams or stakeholders. Highlight your communication skills and how you’ve managed to keep everyone aligned and informed.
✨Prepare for Inspection Readiness Questions
Expect questions about your experience with audits and inspections. Be ready to share how you’ve established oversight practices and supported CAPAs in previous roles, as this will illustrate your commitment to quality and compliance.
