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Clinical Project Manager
Privo Technologies, Inc
- Clinical Operations
The Clinical Project Manager (CPM) will be responsible for the operational management and oversight of clinical trials. The level of independence and scope of responsibilities assigned may vary depending on the experience. The CPM provides oversight of vendors, contractors and consultants and works closely with our Development Team, CEO and the CMO and other cross-functional representatives, including Clinical Data Management, Biostatistics, Regulatory, QA and CMC Project Manager. The CPM will ensure successful completion of all clinical activities/project deliverables within the required time frame and budget.
Key areas of responsibility include:
- Write or contribute to preparation of clinical documents such as plans, protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related materials.
- Write or contribute to preparation of clinical part of regulatory documents (IMPD, IND, IB, briefing packages…).
- Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
- Oversee performance of vendors, to ensure compliance with study protocol and are in accordance with scope of work; identify areas of concern and escalate within PrivoTechnologies and to the appropriate Vendors.
- Perform clinical data review of data listings and summary tables, including query generation.
- Review the statistical report and clinical study report- Write or contribute to preparation or review of publications related to clinical studies.
- Track and report on progress of study including site activation, patient enrollment, monitoring visits.
- Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team.
- Investigate issues, monitor discrepancies, and follow up until resolution.
- Assist in identification and selection of investigation sites, and support the sites all along the study in close collaboration with the monitors.
- Follow-up the budget (forecast, engaged) related to the assigned clinical trial- Ensure that work is performed in accordance with scope of work in order to validate vendor invoices.
- Assist with vendor training on protocols and procedures- Assist in identification and selection of appropriate vendors.
Ability to coordinate a project in connection with internal and external stakeholders - CRO oversight- Project management, with strong written and verbal skills. Must be proficient in PowerPoint and Excel.
Consulting to Full-time
Job Type: Full-time
- Clinical: 1 year
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