Program Director jobs in United Kingdom

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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.