Life Sciences Recruitment in Clinical Development at Aurigene

Aurigene is a clinical stage biotech company engaged in discovery and clinical development of novel and best-in-class therapies to treat cancer, and a wholly owned subsidiary of Dr Reddy's Laboratories Ltd. Aurigene is focused on precision - oncology and has multiple compounds at different stages of pre-clinical development and several projects in global clinical development.

Post : Assistant Clinical Project Manager / Clinical Project Manager - Clinical Development

Job Description
• Act as a Project Lead for the assigned clinical trials while supervising CRAs in their functions of monitoring and administration of clinical trials.
• To manage service providers, CRO and Vendors, collect quotes (budget proposals), summarize & present the same to the management team.
• Provide support with regulatory authority applications and approvals.
• Manage the clinical trials which have been assigned by the Clinical Manager or Head, Clinical Development.
• To assure appropriate site selection, proper site set up, notification/ submissions to regulatory or Ethics Committees (ECs) and execution of Clinical Trial Site Agreements (CTA).
• Develop and maintain the clinical trial operational plans including timelines, budget, and resource requirements within a therapeutic area and in adherence to organizational SOPs.
• Develop and construct content for risk mitigation plans to ensure clinical trials are conducted on time and within budget.
• To generate a Project Management Tracker/Plan listing the tasks related to study planning, conduct and closeout.
• Review and contribute to Clinical Protocols, Investigator s Brochures (IBs), Case Report Forms (CRFs), Informed Consent Forms (ICFs), Pharmacy Manuals, Laboratory Manuals etc. from an operational perspective.
• Assure proper project kick-off meetings and ensure the availability of study progress reports for the extended team.
• To assure proper Investigational Medicinal Products (IMPs) management.
• Participate in patient identification activities and the development of patient recruitment plans and backup plans.
• To identify, recruit, and approve clinical investigators in collaboration with Medical Monitor and Clinical Operations leadership.
• Ensure that all supportive study-related documents like Monitoring Plan, Study Reference Manual, Laboratory Manual, Pharmacy Manual, CRF Completion Guidelines, etc. are completed.
• Ensure that all monitoring activities and processes are completed in compliance with internal company SOPs and GCP/ICH/regulatory guidelines and all internal and external resources are well trained.
• Assure the proper reconciliation of the TMF, appropriate Site Closeout, and archival of the study documents.
• To recommend and implement innovative process ideas that impact clinical trials and/or clinical program management

Candidate Profile
Degree in life sciences or relevant discipline with over 5 years of experience in managing clinical trials and related operational aspects. At least 2 years of experience as a Clinical Project Manager or at least 3 years as an APM (Assistant Project Manager).

Location : Bangalore
Last Date : 20th January 2025