Clinical Trials Leader

Purpose of the Role

The Senior Clinical Research Operations Manager is responsible for the leadership and execution of clinical trials that support the regulatory approval of new medical devices. This role involves comprehensive oversight of study planning, budgeting, project management, staff supervision, and reporting. The Manager ensures all clinical trial activities are conducted in compliance with company procedures and international regulations, while effectively prioritizing and allocating the work of the study staff.

Key Responsibilities

• Plan, lead, and close feasibility and pivotal clinical trials effectively.
• Apply expert knowledge of regulatory requirements for clinical trials.
• Conduct site selection and define recruitment strategies, including risk analysis and mitigation planning.
• Manage study budgets, timelines, and overall project deliverables.
• Oversee vendor selection and management throughout the study lifecycle.
• Supervise study staff, ensuring appropriate work allocation and site compliance.
• Lead the development and standardization of work instructions and operating procedures.
• Provide oversight of Trial Master File (TMF) development, maintenance, and reconciliation.
• Review critical study documents (protocols, clinical study reports, manuals of operations, reference guides, etc.).
• Collaborate closely with Data Management, Product Development, and other cross-functional teams.

Qualifications