CLINICAL PROJECT MANAGER
Responsibilities Assigned :
- Lead pivotal development program(s).
- Team Mentoring, Motivating, Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs).
- Oversee and manage all operational aspects of phase I-IV US based or global clinical trials
- Act as primary point of contact for internal and external team for planning, conduct, and reporting of assigned trials.
- Participate in vendor selection process with assigned PMO representative. This includes proposal development, bid-defense process, and contract review.
- Act as primary point of contact from clinical operations for assigned trials.
- Oversee study start up activities of CROs (e.g. Site identification, Feasibility, Site selection, Contract negotiation and Clinical Study Agreement finalization, Translations, EC and Regulatory submission, Site initiation etc.).
- Oversee, manage and assess vendor performance (timelines and deliverables).
- Develop team and process for carrying out start up (site identification, feasibility, selection, EC submission, contracting and SIV readiness) for some sites in US for a faster FPI in a Global or US only study.
- Budgets- prepare / review budgets for studies managed in house and review professional fee and pass through costs for CROs, SMOs, Investigators, and vendors, as applicable.
- Support Functional Head in preparation of annual studies budget and department budget.
- Manage and track study budget, project milestones, and timelines throughout the life of the study and perform contract reconciliation at study end.
- Plan study activities and timelines and share with stakeholders, set up tracking tools for assigned trials & assess progress as per pre-set timelines.
- Co-ordinate finalization of IP label & requisition. Forecasting of IP requirement during the study and prepare IP requisition.
- Prepare / Review study plans for in-house / outsourced studies. Train study team on trial documents, processes & assigned SOPs.
- Plan and Facilitate vendor kick-off meetings and Investigator Meetings for study.
- Meet investigators and key opinion leaders for assigned trials.
- Drive subject recruitment for assigned studies and meet predefined timelines.
- Prepare and implement Quality control plan in assigned studies and ensure that clinical studies (in-house or outsourced) are in compliance with ICH-GCP, SOPs, and applicable regulations.
- Coordinate with cross functional groups for required deliverables.
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