Founded in 2001, we are a clinical-stage biopharmaceutical company focused on delivering ground-breaking cancer therapeutics to patients globally.
Post : Clinical Project Manager
Roles & Responsibilities
1. End-to-End Study Management: Lead the planning, execution, and oversight of clinical trials across Phase I, II, and III studies.
2. Project Planning & Delivery: Develop and manage study timelines, project plans, budgets, risks, and key deliverables.
3. Cross-Functional Collaboration: Coordinate activities across Clinical Operations, Medical Monitoring, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, and Translational Research teams.
4. CRO and Vendor Management: Manage CROs, vendors, central laboratories, and external partners to ensure high-quality study execution.
5. Study Performance & Risk Management: Monitor study performance, proactively identify risks, and drive mitigation strategies.
6. Regulatory and Quality Compliance: Ensure compliance with ICH-GCP, applicable global clinical trial regulations, and organizational SOPs.
7. Study Start-up and Execution: Support study start-up, site management, patient recruitment strategies, and database lock activities.
8. Reporting and Communication: Prepare and present project updates to senior leadership and governance committees.
9. Stakeholder Engagement: Work closely with investigators, CROs, and external partners to ensure successful study delivery.
Experience & Qualification
• Advanced degree or Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Medicine, or a related discipline.
• 10–12 years of overall experience in clinical research and clinical operations.
• Minimum 3–4 years of direct experience as a Clinical Project Manager.
• Experience working with CROs and managing external vendors.
• Strong knowledge of ICH-GCP, global clinical trial regulations, and quality standards.
• Excellent project management, stakeholder management, and communication skills.
Work Location : Bengaluru
Position Type : Full Time
Work Mode : On-Site
Share your resume at Email : tamil_s@aurigene.com
Last Date : 20th November 2026
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