CT Clinical Study Manager
Philips
full-time
Posted on:
Location Type: Remote
Location: Remote • Alabama, Connecticut, District of Columbia, Florida, Maryland, Massachusetts, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, Vermont, Virginia, Wisconsin • 🇺🇸 United States
Visit company websiteSalary
💰 $101,250 - $181,440 per year
Job Level
Mid-LevelSenior
Tech Stack
Google Cloud Platform
About the role
- responsible for the execution and regulatory compliance of clinical studies for Computed Tomography business
- Manages and executes clinical studies with strict adherence to protocols, regulatory standards (ISO, GCP, FDA), and Philips procedures
- Provides expert guidance and support to study sites and investigators on regulatory requirements, protocol adherence, and Good Clinical Practice
- Enhances and streamlines clinical research processes through continuous data review, process optimization, and proactive resolution of queries and discrepancies
- Collaborates and communicates effectively with internal cross-functional teams and external partners
- Monitors study progress, milestones, and budgets, conducts trend analysis for risk mitigation, and delivers timely study updates and recommendations to leadership and senior management
Requirements
- 3+ years of related experience in clinical research execution in the medical device industry
- Experience using EDC, CTMS, and eTMF systems is highly preferred
- profound knowledge of clinical research process legislation and ICH-GCP guidelines
- Bachelor’s/master’s degree or higher in Life Sciences or an equivalent field
- Must be able to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation
- demonstrated strong analytical, project management, and communication skills; thrive in cross-functional environments
- committed to maintaining high standards of data integrity and regulatory compliance
- Must be willing to travel up to 50% globally to study sites
Benefits
- generous PTO
- 401k (up to 7% match)
- HSA (with company contribution)
- stock purchase plan
- education reimbursement
- other compensation, such as an annual incentive bonus
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical research executionregulatory compliancedata reviewprocess optimizationtrend analysisrisk mitigationprotocol adherenceGood Clinical Practiceclinical studies managementanalytical skills
Soft skills
communication skillsproject managementcross-functional collaborationproblem-solvingleadershiporganizational skillsinterpersonal skillsadaptabilityattention to detailtime management
Certifications
Bachelor’s degree in Life SciencesMaster’s degree in Life SciencesICH-GCP certificationISO certificationGCP certification