Manager TMF Team Lead

Title - 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 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 :

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!

Date Posted

23-Oct-2025

Closing Date

30-Oct-2025

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.

Required Experience :

Manager

Key Skills

Law Enforcement,ABB,Marine Biology,Filing,Automobile,AV

Employment Type : Full-Time

Experience : years

Vacancy : 1