AstraZeneca, a global leader in biopharmaceutical innovation, is hiring Manager and Senior Manager โ TMF Team Lead positions at its Manyata Tech Park, Bangalore location. These roles are perfect for experienced clinical documentation professionals who want to lead TMF (Trial Master File) operations, ensure regulatory compliance, and manage global teams supporting clinical trials worldwide.
With a hybrid 3/2 work model, AstraZeneca offers a flexible, inclusive, and growth-driven work environment where you can truly make an impact in advancing life-changing medicines.
๐ผ Open Positions
1. Manager โ TMF Team Lead
- Location: Manyata Tech Park, Bangalore
- Schedule: 3 days on-site, 2 days remote
- Work Hours: 9 AMโ6 PM or 2 PMโ11 PM IST (transport provided)
- Career Level: D โ Team Lead
Key Responsibilities:
- Ensure TMF inspection readiness and compliance with GCP guidelines.
- Manage TMF setup, maintenance, and close-out activities.
- Conduct quality checks, audits, and documentation reconciliation.
- Lead and train internal teams and CRO vendors.
- Generate TMF metrics and participate in inspections.
Qualifications:
- Bachelorโs degree in life sciences or healthcare.
- Proven experience managing Trial Master File (TMF) in clinical trials.
- Knowledge of ICH-GCP and eTMF systems.
- Excellent leadership, organizational, and communication skills.
Preferred:
Masterโs degree, AstraZeneca systems knowledge, and prior regulatory inspection experience.
2. Senior Manager โ TMF Team Lead
- Location: Manyata Tech Park, Bangalore
- Schedule: 3 days on-site, 2 days remote
- Work Hours: 9 AMโ6 PM or 2 PMโ11 PM IST
- Career Level: E โ Team Lead
Key Responsibilities:
- Lead TMF operations and mentor Managers and Analysts.
- Ensure inspection-readiness across global TMF operations.
- Develop TMF management strategies and process improvements.
- Oversee regulatory audit preparations and reporting.
- Collaborate cross-functionally with QA, Regulatory, and IT teams.
Qualifications:
- Bachelorโs in life sciences, healthcare, or pharmacy.
- 5+ yearsโ experience in TMF/eTMF management.
- Leadership experience managing large documentation teams.
- Strong understanding of DIA Reference Model and ICH-GCP.
Preferred:
Advanced degree, global TMF experience, and AstraZeneca process familiarity.
๐ฏ Why Join AstraZeneca?
- Work with a global leader in clinical innovation.
- Hybrid model โ flexible balance between office and remote work.
- Diverse and inclusive work culture.
- Career growth opportunities through global exposure.
- Be part of a mission-driven organization making an impact in healthcare.
๐ How to Apply
Apply online before October 31, 2025, via AstraZenecaโs official career portal.
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