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: D - Team Lead

About role:
The GBS TMF Manager is accountable for the overall management, integrity, and inspection readiness of the Trial Master File (TMF) across assigned clinical trials. This includes coordination of TMF activities, quality assurance, and compliance with internal policies and regulatory requirements. The TMF Manager works closely with clinical project teams and vendors to ensure timely and accurate documentation throughout the trial lifecycle.

Accountabilities & Responsibilities:

• Ensure inspection readiness and regulatory compliance of TMF at all times for assigned studies

• Oversee TMF set-up, maintenance, and close-out processes in accordance with internal SOPs and GCP guidelines

• Conduct regular TMF reviews, quality checks, and reconciliation to identify and resolve documentation gaps

• Lead and train study teams and vendors in TMF standards, procedures, and best practices

• Liaise with internal/external stakeholders to ensure complete, timely, and accurate document collection and filing

• Prepare TMF metrics/reports and present findings to clinical management

• Support audits and regulatory inspections by providing relevant TMF materials and expertise

• Drive continuous improvement initiatives in TMF processes and technologies

Typical People Management Responsibility (direct/indirect reports)

• Approx. number of people managed in total (all levels) - Yes, 15

• Matrix Manager – (projects/dotted line) - No

• Manager of a team - Yes

• Manager of a Manager - No

Essential skills and qualifications:

• Bachelor’s degree in life sciences, health care, or related discipline

• Experience managing Trial Master File (TMF) in a clinical trials environment; managerial experience required

• Strong knowledge of ICH-GCP, regulatory requirements, and clinical documentation processes

• Excellent attention to detail, organizational, and communication skills

• Proficiency in electronic TMF systems (eTMF)

• Ability to train and influence teams and vendors

Desirable skills and qualifications:

• Master’s degree or professional certification in clinical research/document management

• Experience in managing TMF within a global or multi-country clinical trial environment

• Familiarity with AstraZeneca systems and processes

• Experience in supporting regulatory inspections (FDA, EMA, etc.)

Key Relationships to Reach Solutions

• Internal (to company or team) Clinical Project Managers, Clinical Operations Team, Quality Assurance Team, Regulatory Affairs, IT/Systems Teams, TMF co-ordinators

• External (to company) CROs and Clinical Vendors, Regulatory authorities (as needed during inspection, 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!