Senior Manager TMF Team Lead

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:
TheGBS TMF Team Leadis 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:

• Bachelors 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 (Masters 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 -person working gives us the platform we need to connect work at pace and challenge perceptions. Thats why we work on average a minimum of three days per week from the office. But that doesnt mean were 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 youll 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 youll 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!

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds with as wide a range of perspectives as possible and harnessing industry-leading skills. We believe that the more inclusive we are the better our work will be. We welcome and consider applications to join our team from all qualified candidates regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment) as well as work authorization and employment eligibility verification requirements.