Project Manager – Clinical Trials & Publications
Location: Mumbai, India (Commerz)
Employment Type: Full-Time, Permanent
Application Deadline: January 20, 2026
Job ID: R-242858
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines for some of the world’s most serious diseases. With a patient-focused approach, AstraZeneca combines innovative science with robust clinical expertise to improve patient outcomes globally. Our inclusive culture champions diversity, collaboration, and lifelong learning, making AstraZeneca a dynamic workplace for growth and professional development.
Role Overview
The Project Manager – Clinical Trials & Publications will oversee and manage clinical trials, observational studies, and publication activities across therapeutic areas. This role ensures that projects are executed on time, within budget, and in compliance with regulatory standards (ICH-GCP, SOPs, and local regulations). The ideal candidate will coordinate with external service providers (CROs), internal medical and clinical teams, and investigators to maintain high-quality project execution.
This position is critical for maintaining trial integrity, compliance, and timely delivery of study milestones while supporting the generation of scientific publications.
Key Responsibilities
Clinical Trial Management:
Oversee and manage the full lifecycle of clinical and observational studies from start-up to database lock (DBL) and Clinical Study Report (CSR)
Collaborate with CROs, investigators, and internal stakeholders to ensure project objectives, timelines, and quality standards are met
Develop study protocols, Case Report Forms (CRF), Informed Consent Forms (ICF), and related clinical documents
Prepare monitoring, SDV, and QC plans for clinical studies
Conduct quality control review of study documentation, CRO deliverables, and site activities
Ensure compliance with SOPs, ICH-GCP guidelines, protocol requirements, and local regulations
Manage CAPA (Corrective and Preventive Actions) to maintain GCP compliance and reliability of trial data
Budget & Vendor Management:
Prepare clinical trial budgets and obtain management approval
Identify, select, and negotiate contracts with External Service Providers (CROs, DM, central labs, translation/printing vendors)
Track and manage study-related costs to ensure budget adherence
Publication Management:
Support preparation, review, and submission of publications in alignment with AstraZeneca’s publication policy
Collaborate with medical colleagues and COE teams to generate high-quality scientific content
Stakeholder & Team Collaboration:
Serve as the primary liaison between project teams, external vendors, and internal stakeholders
Provide guidance, mentorship, and support to junior team members
Report on study progress, milestones, and deliverables to management and sponsors
Experience & Qualifications
Required:
Degree in Pharmacy, PharmD, Life Sciences, or a related clinical discipline
Minimum 5 years of experience in clinical trials management, observational studies, or medical publication management
Proven experience working with CROs, investigators, and cross-functional teams in clinical research
Strong understanding of ICH-GCP guidelines, SOPs, and regulatory requirements
Excellent communication, project management, and stakeholder management skills
Preferred:
Postgraduate qualification in Life Sciences, Pharmacy, or Clinical Research
Experience in global or multi-regional trials
Knowledge of publication planning and scientific writing processes
Why Join AstraZeneca – Mumbai
Work for a global, patient-focused biopharmaceutical leader
Opportunity to manage high-impact clinical trials and publications across therapeutic areas
Collaborate with international teams and top-tier external service providers
Career growth in clinical project management, regulatory compliance, and scientific publications
Inclusive, diverse, and empowering work culture that supports continuous learning
SEO & GEO Keywords
Project Manager Clinical Trials Mumbai, Clinical Research Jobs India, AstraZeneca Careers, Publication Management Jobs, CRO Project Manager India, Pharmaceutical Clinical Project Manager
AstraZeneca is an equal opportunity employer, committed to building a diverse and inclusive workforce. All qualified candidates are encouraged to apply, regardless of race, color, ancestry, religion, sex, national origin, age, disability, gender identity, or other protected status.
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