Job Description:
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 that's how we change the lives of patients for the better. And that's 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
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Location:
Austin, Tx
Business Unit:
QA/RA/CA
Role Summary:
The Sr. Manager Company Initiated Studies (CIS) US oversees the planning, execution, and management of clinical studies to ensure compliance with regulatory guidelines, quality standards, and project timelines. This role involves collaboration with cross-functional teams, including Clinical Strategy, Clinical Operations, Data Management, Marketing, Sales and Scientific Communication, and requires a proactive approach to problem-solving 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 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.
- 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 (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, is considered a strong advantage.
Work Environment | Physical Demands:
- Willingness to travel (up to 30%)
"Creating better together". It's the Enovis purpose, and it's 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 work-related 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.
ABOUT ENOVIS™
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.
EOE AA M/F/VET/Disability Statement
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, religion, color, national origin, sex, protected veteran status, disability, or any other basis protected by federal, state or local laws.