Senior Clinical Trial Manager

Senior Clinical Trial Manager

Join our dynamic team as a Senior Clinical Trial Manager where you will play a pivotal role in leading, overseeing, planning, and executing assigned clinical studies. Collaborate closely with the Clinical Program Manager and other departments to ensure the successful delivery of key project milestones.

Responsibilities :

• Collaborate with the Clinical Program Manager to lead and oversee clinical studies, ensuring timely execution and delivery of key deliverables.
• Work closely with Clinical Outsourcing to select CROs and vendors, manage RFI, RFP, bid defenses, and handle contract and budget negotiations.
• Make primary decisions on CRO and vendor selection alongside the Clinical Program Manager and Director of Clinical Outsourcing.
• Oversee relationships with CROs, vendors, field monitors, and other partners; establish and maintain strong relationships with investigators, study coordinators, site personnel, and other external stakeholders.
• Develop and manage study budgets and financial reporting, including monthly and quarterly financial reconciliation and forecasting.
• Monitor study status and timelines, providing data for performance metrics reporting.
• Work with the Patient Recruitment department to strategize recruitment efforts, meet enrollment projections, and achieve established targets.
• Oversee the development of clinical study documents including ICF, monitoring plans, and recruitment plans.
• Lead and participate in internal cross-functional clinical team meetings, serving as the main point of contact for study-level status updates.
• Provide study-level updates at management meetings and other forums.
• Coordinate study start-up activities with relevant departments, including feasibility studies and regulatory document preparation.
• Participate in database creation, user acceptance testing, and data cleaning activities.
• Contribute to SOP development, process mapping, and training of junior CTMs and CTAs.
• Directly manage and supervise CTMs and / or CTAs, conducting performance reviews and supporting their professional development.

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