Reporting to the Sr. Management, this role will be a key business partner and other management team in the development and execution of the Company’s clinical strategic plans.
This role is a collaborativeand high-impact position, requiring the ability to integrate the Functional teams, Quality, PM and IT functions tightly into the Company’s clinical programs.
This leader will also build upon the strong foundation of the process and informatics needed to support continued growth.
Accountable for overall direction of multiple, functions or projects, which may contain wide scope & geographical diversity in Medical Devices Diagnostics and BioPharma
Lead and manage multiple clinical programs through the direct supervision of additional Clinical Operations teams
Accountable for the execution of assigned clinical program(s) in compliance with quality standards (including ICH GCP, local regulations and Client SOPs), on schedule and on budget.
Accountable for the oversight of other vendors to meet Project obligations.
Accountable for program budget planning and external spend related to program execution.
Works closely with Global Program Management, and Finance to ensure budgets, enrollment, and gaiting are accurate; ensures communication of program status, cost and issues to inform timely decision-making by senior management.
Provide TA-level direction to COPLs/APLs for the development of operational plans including enrollment models and risk management plans, financial planning and management, communication plans, and monitoring plans.
Line Manager for Clinical Operations staff.
Mentors and develops employees to expand employee performance levels and assure retention of high performing employees
Ensures appropriate employee resources are available to meet corporate/ client/ project objectives while achieving optimal billability of clinical operations staff
Ability to perform business travel, up to 25%
All other responsibilities as assigned