Pharm'Up 
AstraZeneca, a global leader in biopharmaceuticals, is seeking a highly skilled Project Manager for Trials and Publication to join their team in Mumbai. This role is essential for managing the lifecycle of clinical and non-interventional studies, ensuring that scientific data is not only gathered with integrity but also published in accordance with global standards.
The successful candidate will act as the primary bridge between AstraZeneca, external service providers (CROs), and medical investigators to deliver high-quality clinical evidence.
Key Responsibilities & Scope
This role involves a dual focus on rigorous trial management and the strategic dissemination of results through publications.
Clinical Trial Management
- Operational Oversight: Lead the initiation, conduct, and delivery of non-interventional studies (local, regional, and global) across various Therapeutic Areas (TAs).
- Vendor Management: Identify, select, and manage External Service Providers (ESPs) including CROs, Data Management teams, and central laboratories.
- Compliance: Ensure every study phase adheres to ICH-GCP guidelines, AstraZeneca SOPs, and local regulatory requirements.
- Financial Planning: Prepare clinical trial budgets, negotiate costs with purchase teams, and secure management approval.
Study Design & Quality Control
- Documentation: Assist in designing critical documents such as the Study Protocol, Case Report Form (CRF), and Informed Consent Form (ICF).
- Monitoring & QC: Develop Monitoring Plans and Source Data Verification (SDV) strategies. Conduct Quality Control reviews of study documents and site visits.
- Data Integrity: Implement Corrective and Preventive Actions (CAPA) during trials to ensure data reliability and GCP compliance.
Publication & Results
- Publication Management: Manage the end-to-end publication process, ensuring all activities strictly adhere to the company’s Publication Policy and ethical standards.
- Timeline Accountability: Oversee the project from study start-up through to Database Lock (DBL) and the final Clinical Study Report (CSR).
Candidate Profile
AstraZeneca is looking for a PharmD professional with specific experience in observational studies and medical publishing.
- Qualification: PharmD (Doctor of Pharmacy) or equivalent professional degree. A post-graduate qualification is preferred.
- Experience: Proven track record in handling clinical trials, observational studies, and Publication/ESR (External Scientific Research) management.
- Technical Skills: Deep understanding of ICH-GCP, SDV processes, and budget negotiation.
- Interpersonal Skills: Strong coordination skills to manage CROs and collaborate with internal medical colleagues.
Additional Information
- Location: Mumbai (Commerz), Maharashtra.
- Functional Area: Trials and Publication.
- Application Deadline: 15 February 2026.
How to Apply
Qualified candidates should submit their applications through the AstraZeneca Careers Portal. Focus your CV on your experience with vendor oversight, budget management, and your familiarity with the publication standards for clinical research.
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