Proprietor at ApicalGo Consultancy
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Project Manager - Pharma (7-11 yrs)
The Project Manager Independently or in consultation with the Sponsor/CRO will:
- Locate and select clinical investigators appropriate to the therapeutic area and phase of the study.
- Assess potential study sits to ensure the facility, staff and patient population are sufficient for study conduct.
- Negotiate the study budget (grant) and any other contract agreements required by the Sponsor/CRO, if required.
- Plan or assist in conducting study start-up meetings.
- Meet with Clinical Investigators and their staff prior to study initiation to ensure all aspects of the study are understood by the investigator and staff, confirm the appropriateness of the IRB and ensure that all documentation required to initiate the study is complete.
- Monitor study progress to assure compliance with protocol requirements, FDA regulations and Good Clinical Practice by conducting site visits as directed by the Sponsor/CRO.
- Monitor and track patient enrollment and study progress.
- Perform site audits to include source document review.
- Ensure the track patient enrollment and study progress
- Identify, address, and resolve issues and problems as they might occur.
- Review reports & communicate to sponsor within the specified timelines
At study Completion:
- Ensure collection of all data and remaining study supplies for return to the Sponsor/CRO.
- Ensure that appropriate study documents are complete and properly filed.
- Prepare the site for possible FDA inspection.
- Assist the Sponsor/CRO in problem solving and provide consultation on monitoring and study related activities.
The position also involves:
- Coordinating with vendors as applicable for the study.
- Coordinating with the PIs for site contracts.
- Ensuring Clinical Trial Material compliance if applicable.
- One point of contact for the sponsors.
- Providing timely updates to the sponsor.
- To strategize for timely enrollment.
- Ensuring the study is completed within budgeted timelines and resources.
- Tracking the enrollment and retention of subjects at each site.
- Supervising a team of CRAs.
- Any other duties as assigned by the supervisor in the department.