AstraZeneca Require TMF Team Lead - B.Pharm, BSc Apply

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines for some of the world’s most serious diseases. But we’re more than one of the world’s leading pharmaceutical companies.

Post : Senior Manager - TMF Team Lead

Job Description
The GBS TMF Team Lead is responsible for the strategic oversight, coordination, and leadership of the GBS TMF Services, ensuring high standards in Trial Master File management and inspection readiness for all assigned clinical trials. This role supervises TMF Managers, and Coordinators, fosters cross-functional collaboration, implements process improvements, and ensures compliance with global regulatory guidance and internal policies. Operational team will be based in India and will provide service globally.

Accountabilities & Responsibilities
• Lead, manage, and mentor the TMF team, including Managers, Analysts, and Administrators
• Oversee the development and execution of TMF management strategies for clinical studies
• Ensure TMF operations are consistently inspection-ready and compliant with ICH GCP, DIA Reference Model, and all relevant regulatory requirements
• Drive continuous improvement through process reviews, technology enhancements, and team training
• Support issue resolution for complex TMF and documentation challenges
• Collaborate with global clinical trial teams, project managers, quality assurance, and IT to ensure seamless TMF processes
• Prepare and present TMF metrics, findings, and improvement plans to senior management
• Act as point of contact for regulatory inspections and internal audits concerning TMF
• Ensure clear communication, workload management, and professional development within the team

Candidate Profile
• Bachelor's degree in life sciences, healthcare, pharmacy, or related discipline
• Minimum 5 years' experience in TMF/eTMF management and clinical documentation; managerial experience required
• In-depth knowledge of DIA Reference Model, ICH GCP, and global regulatory requirements
• Proven leadership and team management skills, including coaching and people development
• Experience with electronic TMF platforms (e.g., Veeva Vault)
• Strong organizational, strategic, and problem-solving abilities
• Excellent communication skills; able to influence cross-functional stakeholders
• Computer proficiency, including advanced use of Microsoft Office suite
• Advanced degree (Master’s preferred) or professional certification in clinical research or document management
• Experience managing global TMF teams and multi-country clinical operations
• Experience supporting regulatory authority inspections (FDA, EMA, etc.)
• Familiarity with AstraZeneca clinical systems and procedures

Additional Information
Experience : 5 years
Qualification : Bachelor's degree in life sciences, healthcare, pharmacy
Location : Bengaluru, Karnataka, India
Job ID : R-237526
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th November 2025