Manager Clinical Operations- Medical Device

Manager, Clinical Operations (Medical Device)
Location: Plano, Texas

Job Description

Company Overview:
A global manufacturer of specialty medical products is seeking a Manager, Clinical Operations to join its team. With a strong reputation for delivering best-in-class medical devices across interventional radiology, vascular surgery, interventional cardiology, and oncology, this company is committed to improving patient outcomes through percutaneous, image-guided procedures. The organization operates with a values-driven culture, fostering collaboration and innovation.

Position Overview:

The Manager, Clinical Operations will oversee all clinical activities related to a portfolio of clinical studies and lead daily in-house operations. This role will independently manage multiple clinical studies, provide leadership to a team of Clinical Affairs Managers, and drive strategic clinical initiatives.

Key Responsibilities:

• Provide leadership in the execution of pre-market and post-market clinical studies.
• Represent the company's clinical research interests within the region and gather insights from customers and regulatory authorities.
• Build and maintain strong relationships with internal and external stakeholders.
• Manage global and local clinical research projects across the company's portfolio.
• Ensure clinical programs align with applicable regulations, guidelines, and policies.
• Lead development and revisions of clinical study protocols, Instructions for Use (IFU), Case Report Forms (CRFs), and other essential documentation.
• Oversee clinical study accuracy, compliance, and budget management.
• Act as a key representative during audits and regulatory interactions.
• Collaborate with cross-functional teams to drive clinical and company-wide initiatives.
• Oversee third-party vendors such as Contract Research Organizations (CROs) and core labs.
• Support post-clinical activities and product market launches.

Qualifications & Skills:

• Bachelor's degree in engineering, life sciences, or a related medical/scientific field (advanced degree preferred).
• Minimum of 7 years of Clinical Research experience, including 5+ years in a leadership role.
• Professional certification (e.g., ACRP, SOCRA) preferred.
• Medical device industry experience, particularly in interventional radiology and/or cardiovascular fields.
• Strong experience managing direct reports and clinical teams.
• Proven expertise in clinical trial design, execution, and regulatory compliance.
• Cost-center and study budget management experience.
• Global clinical trial strategy and execution experience.
• Product development exposure, including global clinical strategy development.
• Ability to travel up to 40%.

This is an exciting opportunity to take on a leadership role in a growing clinical team and contribute to innovative medical advancements.