Position: Assistant Clinical Project Manager / Clinical Project Manager – Clinical Development
Location: Bangalore
Company: Aurigene
Desired Profile:
- Degree in Life Sciences or a related field.
- Over 5 years of experience managing clinical trials and associated operational tasks.
- At least 2 years of experience as a Clinical Project Manager (CPM), or at least 3 years as an Assistant Clinical Project Manager (APM).
Roles and Responsibilities:
- Lead assigned clinical trials and supervise Clinical Research Associates (CRAs) in monitoring and trial administration.
- Manage service providers, CROs, and vendors by collecting quotes, summarizing, and presenting them to the management team.
- Provide support for regulatory authority applications and approvals.
- Oversee clinical trials assigned by the Clinical Manager or Head of Clinical Development.
- Ensure appropriate site selection, setup, and completion of regulatory submissions (Ethics Committees, CTAs, etc.).
- Develop and maintain operational plans for clinical trials, including timelines, budgets, and resource allocation.
- Construct and implement risk mitigation plans to ensure clinical trials are on time and within budget.
- Track project tasks related to study planning, conduct, and closeout through a Project Management Tracker/Plan.
- Review and provide operational feedback on key documents (Protocols, Investigator’s Brochures, CRFs, ICFs, Pharmacy and Laboratory Manuals, etc.).
- Coordinate project kick-off meetings and ensure study progress reports are made available to the extended team.
- Ensure proper management of Investigational Medicinal Products (IMPs).
- Assist with patient recruitment planning and identification activities.
- Collaborate with the Medical Monitor and Clinical Operations leadership to recruit and approve clinical investigators.
- Ensure study-related documents (Monitoring Plans, CRF Completion Guidelines, etc.) are completed.
- Ensure that monitoring activities comply with internal SOPs, GCP/ICH/regulatory guidelines.
- Support the reconciliation of the Trial Master File (TMF), site closeouts, and archival of study documents.
- Recommend and implement process innovations to enhance clinical trials or clinical program management.
How to Apply:
Interested candidates may send their resume to: gayathiri_n@aurigene.com.
At Aurigene, we are committed to fostering a diverse and inclusive workplace and provide equal opportunities for all.
