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.