Director Clinical Operations

Position: Director, Clinical Operations (Medical Device)

Role Overview:

The Director of Clinical Operations will lead and manage early feasibility, proof of concept, and pivotal clinical studies to meet project and organizational goals. This role involves working closely with cross-functional teams, clinical research organizations, and consultants to ensure the successful and efficient execution of clinical trials.

Core Responsibilities:

• Act as the study lead, overseeing the clinical operations team and coordinating with cross-functional clinical trial teams for planning, execution, and reporting of clinical trials.
• Manage external resources, including consultants, contractors, and CROs.
• Oversee study budgets, including forecasting and approving invoices.
• Coordinate vendor meetings and review vendor documents for adequacy.
• Develop and maintain project plans, schedules, budgets, and milestones.
• Prepare or support the preparation of clinical documents, such as protocols, study manuals, and regulatory submissions, as well as standard operating procedures and guidelines.
• Identify and address departmental training needs for internal and external operations.
• Ensure compliance with trial protocols, ICH/GCP guidelines, and applicable SOPs and regulations.
• Supervise direct reports and matrixed study teams.
• Maintain the highest standards of compliance and professionalism.

Minimum Qualifications:

• Bachelor’s or RN degree.
• At least 10 years of experience in Clinical Operations roles, with a minimum of 5 years as a study manager or lead at a medical device company.
• Proven experience managing at least one successful CRO clinical trial.
• Strong knowledge of GCP, ICH guidelines, and FDA regulations.
• Understanding of project management principles and demonstrated ability to lead project teams.
• Ability to work effectively in a fast-paced environment, with excellent organizational skills and self-direction.
• Strong problem-solving skills, a sense of urgency, attention to detail, and capability to execute tasks under time and resource pressures.
• Adaptability to changing priorities and the ability to travel (approximately 35%).

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