Job Description

Title - Senior Manager - TMF Team Lead

Work Location: Manyata Tech Park, Bangalore, India Work Schedule: Three days on-site, two days remote (3/2) Work Hours: 9 am to 6 pm IST or 2 pm to 11 pm IST basis business needs (Transport available as per company policy) Career Level: E - Team Lead

About role:

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

Typical People Management Responsibility (direct/indirect reports)

Approx. number of people managed in total (all levels) - Yes, 65 Matrix Manager - (projects/dotted line) - No Manager of a team - Yes Manager of a Manager - Yes

Essential skills and qualifications:

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

Desirable

skills and qualifications:

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

Key Relationships to Reach Solutions

Internal (to company or team)

TMF Managers& co-ordinators, Clinical Project Managers, Clinical Operations Leadership, Quality Assurance, Regulatory Affairs, IT/Systems Teams

External (to company)

CROs and Clinical Vendors, Regulatory authorities (during inspections), Auditors (external and internal)

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.



AstraZeneca offers an environment where diverse cultures and perspectives come together to create a sense of belonging. Here you'll find opportunities to learn and grow alongside a team committed to transforming processes through simplification and automation. Our innovative approach ensures that data is at the heart of everything we do. As part of our journey of growth and evolution, you'll contribute to making AstraZeneca more agile and efficient while impacting society positively.



Ready to take the next step? Apply now to join our dynamic team!