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.
