Project Manager – Clinical Research
Location: Mumbai, India
Business Unit: Medical Affairs & Clinical Research
Employment Type: Full-Time
Company: Sun Pharma Laboratories Ltd.
Job Summary
The Project Manager – Clinical Research is responsible for planning, managing, and overseeing clinical research projects from initiation through completion. The role involves leading cross-functional teams, managing project timelines and budgets, ensuring regulatory compliance, mitigating project risks, and maintaining high standards of quality throughout the clinical research lifecycle.
The incumbent will work closely with Clinical Operations, Medical Affairs, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, Finance, Procurement, and external partners to ensure successful project execution and delivery.
Key Responsibilities
Clinical Project Management
Lead and manage clinical research projects across multiple therapeutic areas.
Develop comprehensive project plans, timelines, milestones, and resource allocation strategies.
Define project objectives, deliverables, scope, and success criteria in collaboration with stakeholders.
Monitor project progress and ensure timely achievement of project milestones.
Drive project execution while maintaining alignment with organizational goals and clinical development strategies.
Team Leadership & Stakeholder Management
Lead and mentor a team of clinical research professionals.
Coordinate activities across cross-functional departments and external partners.
Facilitate effective communication among project teams and stakeholders.
Conduct regular project review meetings and provide status updates to management.
Foster a collaborative and high-performance team environment.
Resource Planning & Management
Assess project resource requirements and allocate resources effectively.
Assign project responsibilities and monitor workload distribution.
Optimize utilization of personnel, systems, and operational resources.
Ensure adequate staffing and support for project activities.
Budget & Financial Management
Develop and manage project budgets.
Monitor project expenditures and financial performance.
Ensure efficient and cost-effective utilization of resources.
Collaborate with Finance and Procurement teams to manage project-related contracts and budgets.
Track financial risks and implement corrective actions where necessary.
Vendor & Contract Management
Support vendor identification, evaluation, and selection processes.
Manage relationships with CROs, clinical sites, laboratories, and external service providers.
Oversee contract execution and vendor performance.
Ensure outsourced activities meet project timelines, quality standards, and regulatory requirements.
Risk Management
Identify project risks, issues, and potential challenges.
Develop and implement mitigation and contingency plans.
Monitor risk indicators throughout the project lifecycle.
Escalate critical issues to senior management when required.
Ensure proactive problem-solving and issue resolution.
Regulatory Compliance & Governance
Ensure compliance with:
Good Clinical Practice (GCP)
ICH Guidelines
Local and Global Regulatory Requirements
Company SOPs and Quality Standards
Oversee preparation and submission of regulatory and ethics-related documentation.
Coordinate interactions with Ethics Committees, Institutional Review Boards (IRBs), and regulatory authorities.
Ensure project activities adhere to all applicable compliance requirements.
Quality Management
Implement quality control and quality assurance processes throughout project execution.
Ensure data integrity, accuracy, and completeness.
Support audit readiness and inspection preparedness activities.
Monitor project quality metrics and implement corrective actions when required.
Promote continuous improvement and quality excellence within project teams.
Clinical Research Operations Support
Collaborate with Clinical Operations and Medical Affairs teams to support study conduct.
Monitor project deliverables and ensure alignment with study protocols.
Support study start-up, execution, monitoring, and close-out activities.
Ensure smooth coordination between internal and external stakeholders.
Educational Qualifications
Required
Bachelor’s or Master’s Degree in:
Life Sciences
Clinical Research
Biology
Pharmacology
Nursing
Healthcare Sciences
Related Scientific Discipline
Preferred
Post-Graduate Diploma in Clinical Research.
Advanced certification in Clinical Research or Project Management (PMP, PRINCE2, etc.).
Experience Requirements
Required
Minimum 5–10 years of experience in Clinical Research.
Experience managing clinical research projects and cross-functional teams.
Experience working in pharmaceutical, biotechnology, CRO, or healthcare research environments.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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