Sr. Manager, Company Initiated Studies

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 

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