Sr Manager Company Initiated Studies

At Enovis we sweat the little things. We embrace collaboration with our partners and patients and we glory in the grind of scientific excellence with the goal of transforming medical technology as we know it.

Because thats how we change the lives of patients for the better. And thats how we create better together.

As a key member of the Global Surgical Clinical Affairs Department you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title

Sr. Manager Company Initiated Studies

Reports To:

Senior Director Global Surgical Clinical Affairs QA/RA/CA

Location:

Austin Tx

Business Unit:

QA/RA/CA

Role Summary:

The Sr. Manager Company Initiated Studies (CIS) US oversees the planning and management of clinical studies to ensure compliance with regulatory guidelines quality standards and project timelines. This role involves collaboration with crossfunctional teams including Clinical Strategy Clinical Operations Data Management Marketing Sales and Scientific Communication and requires a proactive approach to problemsolving and communication. The Sr. Manager CIS US leads a dedicated team of Clinical Research Associates (CRAs) conducting clinical studies in the field of orthopedic implants and technology applications across the United States. In this role the Sr. Manager CIS US ensures that clinical data is collected on time and in the specified method and quantity.

Key Responsibilities:

• Plan and manage clinical studies ensuring accurate 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.

• We value a strong team and firmly believe that success is achieved together. As a leader you exemplify this mindset and play a pivotal role in shaping our team culture. Your commitment to fostering collaboration and growth ensures that the team thrives and succeeds collectively.

Desired Qualifications:

• A degree in a scientific field Bachelors Masters or PhD) with a focus on medicine medical technology or pharmaceuticals. Expertise with clinical studies on highclass 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 is considered a strong advantage.

Work Environment Physical Demands:

• Willingness to travel (up to 30

Creating better together. Its the Enovis purpose and its what drives us and empowers us every day on a global scale. We know that the power to create better for our customers our team members and our shareholders begins with having the best team pursuing common goals operating at the highest levels and delivering extraordinary outcomes.

What does creating better together mean to us at Enovis Discover the why behind our purpose values and behaviors:

Our Enovis Purpose Values and Behaviors on Vimeo

We offer a comprehensive benefits package that includes:

• Medical Insurance
• Dental Insurance
• Vision Insurance
• Spending and Savings Accounts
• 401(k) Plan
• Vacation Sick Leave and Holidays
• Income Protection Plans
• Discounted Insurance Rates
• Legal Services

EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit experience and other workrelated criteria without regard to race color ethnicity religion national origin sex age pregnancy disability veteran status or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.

Join us in creating better together.