Job Title: Project Manager – Clinical Trials and Publications
Location: Mumbai, Maharashtra, India
Employment Type: Full-Time
Experience Required: 5–8 years in Clinical Trials, Observational Studies, and Scientific Publications
Application Deadline: January 20, 2026
Job Requisition ID: R-242858
About AstraZeneca
AstraZeneca is a global, science-led, patient-focused biopharmaceutical company dedicated to discovering, developing, and commercializing prescription medicines for some of the world’s most serious diseases. Our mission combines innovation, scientific excellence, and patient-centered strategies to improve healthcare outcomes worldwide.
Role Overview
The Project Manager – Clinical Trials and Publications will lead and oversee clinical trial execution, observational studies, and publication projects across therapeutic areas. This role ensures high-quality, timely delivery of projects, collaborating with internal medical teams, external service providers (CROs), and investigators while ensuring compliance with global and local regulations, ICH guidelines, and Good Clinical Practice (GCP).
The role also manages scientific publications in alignment with company policies, supporting the dissemination of clinical evidence to the medical and scientific community.
Key Responsibilities
Clinical Trial & Project Management
Collaborate with external service providers (CROs) and investigators to ensure quality and timely execution of clinical trials.
Manage non-interventional studies locally, regionally, and globally, including study initiation, monitoring, and close-out.
Develop study protocols, case report forms (CRFs), informed consent forms (ICFs), monitoring plans, and quality control (QC) procedures.
Oversee site and investigator selection, ensure SDV (source data verification), and manage CAPA to maintain GCP compliance.
Prepare and manage study budgets, negotiate contracts, and ensure financial approvals.
Track trial progress and milestones, coordinating regularly with CROs and internal stakeholders.
Publication Management
Ensure adherence to the company’s publication policies.
Oversee the planning, development, and delivery of scientific publications, abstracts, and study reports.
Collaborate with medical colleagues to ensure publications accurately reflect clinical data and outcomes.
Compliance & Quality Assurance
Ensure all trials and studies comply with AZ SOPs, ICH guidelines, GCP, and applicable local regulations.
Conduct QC reviews of study documents, CRO deliverables, and monitoring reports.
Support internal audits and inspections to maintain regulatory readiness.
Required Qualifications & Experience
Bachelor’s degree in Pharmacy, Pharm.D., Life Sciences, or equivalent.
5–8 years of experience managing clinical trials, observational studies, or publications.
Strong understanding of ICH guidelines, GCP, and regulatory requirements.
Proven ability to manage projects, coordinate cross-functional teams, and maintain timelines.
Excellent communication, analytical, and problem-solving skills.
Desirable:
Postgraduate or doctoral qualification in a relevant field (MSc, PhD, or Pharm.D.).
Experience with multi-regional trials, study publications, and evidence generation initiatives.
Why AstraZeneca
Join a global, science-led organization that empowers innovation and patient-focused solutions.
Collaborate with diverse experts in a culture that values inclusivity, continuous learning, and career growth.
Contribute to high-impact clinical trials and scientific publications that shape healthcare decisions worldwide.
Access opportunities to advance professionally across global and regional projects.
Application Instructions:
Interested candidates are invited to apply by January 20, 2026 for the role of Project Manager – Clinical Trials and Publications in Mumbai. This is a full-time role offering opportunities to lead clinical studies, manage publications, and contribute to evidence-based medical strategies.
AstraZeneca is an equal opportunity employer, committed to building diverse and inclusive teams. We encourage applications from all qualified candidates and comply with all local and international employment regulations.
I can also create a meta title, meta description, and high-ranking keyword optimization for this post to ensure it ranks globally for “Clinical Trials Project Manager,” “Medical Publications Manager,” and related searches, driving maximum candidate traffic.
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