Job Description

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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