TMF Program Lead

Cencora; United Kingdom; Remote; GBP 50,000 - 70,000; Full time

Job summary

Cencora is seeking a TMF Program Lead for a 6-month remote role based in the UK. The successful candidate will manage Trial Master Files (TMFs), ensuring accuracy and readiness, while fostering relationships with study teams and leading a team to support KPIs.

Qualifications

• Minimum 5 years in a TMF Study Owner or equivalent role.
• Experience with clinical trial lifecycle management.

Responsibilities

• Oversee TMF management, identify improvement strategies.
• Review portfolio metrics and recommend improvements.
• Ensure inspection readiness and support audits.

Skills

Good Documentation Practices (GDP)

TMF Reference Model

Experience with eTMF systems

Knowledge of TMF stakeholders

Job description

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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!

Cencora Pharmalex is a leading service provider for the Pharmaceutical Industry globally, specializing in drug and medical device approval, market development, and product maintenance.

We have an exciting opportunity for a TMF Program Lead to join Pharmalex. This remote role is based in the United Kingdom and initially for 6 months.

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:

1. TMF Management: Oversee TMF management, identify improvement strategies, and share best practices.
2. TMF Metrics: Review portfolio metrics, analyze trends, and recommend improvements.
3. TMF Health: Monitor TMF health at portfolio and vendor levels, gather customer feedback, and provide guidance based on risk analysis.
4. Inspection Readiness: Establish oversight practices, support audits and inspections, and implement CAPAs.
5. Customer Relationships: Maintain relationships with Study Management and Leadership, and communicate trends and issues.
6. Team Management: Manage workload, oversee KPIs, support recruitment, and develop team training programs.

Work Experience:

• Minimum 5 years in a TMF Study Owner or equivalent role.

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Skills and Knowledge:

• 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

What Cencora offers:

Benefits vary by country and are aligned with local market practices. Eligibility and effective dates may differ, especially under collective bargaining agreements.