Leads and oversees all aspects of clinical study management
Ensures compliance with regulatory requirements (ISO, GCP, FDA) and Philips procedures
Serves as a subject matter expert for study sites and investigators
Reviews and verifies study documentation and data for accuracy and compliance
Develops study plans and protocols, managing cross-functional relationships
Monitors study progress, conducts data analysis, and manages risks

Requirements

Minimum of 10 years leading clinical research trials
Experience leading medical device clinical trials
Knowledge and experience with peripheral vascular strongly preferred
Cardiac or coronary experience required
Strong knowledge of relevant regulations, standards, and guidelines (ISO, GCP, etc.)
Familiarity with Cath Lab Operations required
Bachelor's degree or higher in a related field
Consideration for nursing backgrounds with extensive clinical research experience in the cardiac space

Benefits

Generous PTO
401k (up to 7% match)
HSA (with company contribution)
Stock purchase plan
Education reimbursement

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills

clinical study managementdata analysisstudy documentation reviewstudy protocol developmentrisk managementcompliance with ISOcompliance with GCPcompliance with FDAclinical research trialsmedical device trials

Soft skills

leadershipcross-functional relationship managementsubject matter expertisecommunicationorganizational skills