Sr. Manager – Company Initiated Studies
| Company | ENOVIS |
|---|---|
| Location | Austin, TX, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Senior, Expert or higher |
Requirements
- A degree in a scientific field (Bachelor’s, Master’s, or PhD) with a focus on medicine, medical technology, or pharmaceuticals.
- Expertise with clinical studies on high-class medical devices, GCP (Good Clinical Practice), and statistics is highly desirable.
- Strong leadership skills, demonstrating the ability to lead and inspire teams effectively.
- Demonstrated experience in professional collaboration with study surgeons and clinical sites.
- Proven experience in a commercial enterprise with a solid understanding of business operations and strategy.
- Experience working in a global company or organization, with the ability to navigate and adapt to diverse cultural settings.
Responsibilities
- Plan and manage clinical studies, ensuring accurate execution and reliable data collection for orthopedic medical devices.
- Develop and implement scientifically robust methods for study protocol design that meet regulatory and quality standards.
- Lead the qualification process for clinical study sites to ensure compliance with study requirements.
- Conduct training sessions, provide monitoring, and offer support to clinical study sites throughout the study lifecycle.
- Prepare comprehensive study reporting, including key findings and interpretations.
- Monitor and ensure adherence to study protocols, overseeing study progression and determining successful completion.
- Provide updates on clinical study progress and present data to the study sites, project core teams and management.
- Manage clinical trial resources and timelines to ensure project milestones are met.
- Collaborate with internal departments and external partners to complete studies that support regulatory submissions for orthopedic implants and related devices.
- Ensure full compliance with applicable regulations, industry standards, and company quality policies throughout all clinical study activities.
Preferred Qualifications
- A degree in a scientific field (Bachelor’s, Master’s, or PhD) with a focus on medicine, medical technology, or pharmaceuticals.
- Expertise with clinical studies on high-class medical devices, GCP (Good Clinical Practice), and statistics is highly desirable.
- Strong leadership skills, demonstrating the ability to lead and inspire teams effectively.
- Demonstrated experience in professional collaboration with study surgeons and clinical sites.
- Proven experience in a commercial enterprise with a solid understanding of business operations and strategy.
- Experience working in a global company or organization, with the ability to navigate and adapt to diverse cultural settings.