07 Nov
|
Aurigene Oncology
|
Bengaluru
07 Nov
Aurigene Oncology
Bengaluru
As a Clinical Project Manager, you will be responsible for the end-to-end management of oncology clinical studies, working closely with cross-functional teams, investigators, CROs, and external partners to ensure studies are delivered on time, within budget, and in compliance with regulatory and quality standards.
This is a highly collaborative, office-based role that offers the opportunity to contribute directly to the development of novel cancer therapies.
Key Responsibilities
? Lead the planning, execution, and oversight of oncology clinical trials across Phase I, II, and III studies.
? Develop and manage study timelines, project plans, budgets, risks, and key deliverables.
? Coordinate activities across Clinical Operations, Medical Monitoring, Regulatory Affairs, Data Management, Biostatistics, Pharmacovigilance, and Translational Research teams.
? Manage CROs, vendors, central laboratories, and external partners to ensure high-quality study execution.
? Monitor study performance, proactively identify risks, and drive mitigation strategies.
? Ensure compliance with ICH-GCP, applicable regulatory requirements, and organizational SOPs.
? Prepare and present project updates to senior leadership and governance committees.
? Support study start-up, site management, patient recruitment strategies, and database lock activities.
Qualifications & Experience
Essential
- 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.
- Demonstrated experience managing oncology clinical trials.
- Strong understanding of clinical trial operations, study start-up, conduct, and close-out activities.
- 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.
Preferred
- Experience in biotech, pharmaceutical, or oncology-focused research organizations.
- Exposure to global and multi-country clinical studies.
- PMP or equivalent project management certification.
What We Are Looking For
We are seeking a proactive, detail-oriented leader who can effectively manage complexity, influence cross-functional teams, and drive operational excellence in a fast-paced oncology research environment. The ideal candidate combines robust project management expertise with a passion for bringing innovative cancer therapies to patients.
📌 Clinical Project Manager (Bengaluru)
🏢 Aurigene Oncology
📍 Bengaluru