Aurigene Oncology
We are Hiring!
Assistant Clinical Project Manager / Clinical Project Manager – Clinical Development
Desired 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.
Roles and Responsibilities:
•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.
Interested candidates may send their resume to: gayathiri_n@aurigene.com
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