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Assistant Project Manager Clinical Development

Aurigene Discovery

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2-5 Years
3 months ago
122 Viewed
4 Applied

Job Description

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).

Job Description, Key Skills and Competencies:

  • 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
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Last Updated: 12-04-2024 09:43:08 AM
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