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:
TheGBS TMF Manageris 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:

• Ensureinspection readinessand regulatory compliance of TMF at all times for assigned studies

• OverseeTMF set-up maintenance and close-outprocesses in accordance with internal SOPs and GCP guidelines

• Conductregular TMF reviews quality checks and reconciliationto identify and resolve documentation gaps

• Lead and train study teams and vendors inTMF 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:

• Bachelors 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 ofICH-GCP regulatory requirements and clinical documentation processes

• Excellentattention to detail organizational and communication skills

• Proficiency inelectronic TMF systems (eTMF)

• Ability to train and influence teams and vendors

Desirable skills and qualifications:

• Masters degree or professional certification in clinical research/document management

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

• Familiarity withAstraZeneca 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 -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!