Clinical Project Manager (Medical Device / Digital Health)

job summary:
Are you ready to champion the launch of life-saving healthcare technologies? As a Clinical Project Manager, you will plan and execute global clinical development plans for critical drugs and medical devices. Partnering cross-functionally with engineering, regulatory, and marketing teams, you will directly generate the data that powers global regulatory submissions and transforms patient care.

location: Telecommute
job type: Contract
salary: $75.00 - 80.36 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:

• Study Planning & Execution: Develop end-to-end clinical study plans, managing timelines, budgets, protocols, case report forms, and informed consents.
• Vendor & Site Management: Provide day-to-day oversight of CRO personnel, identify and train study sites, and negotiate research agreements and budgets.
• Monitoring & Closeout: Formulate monitoring plans, manage trial resources, and oversee interim visits and study closeout procedures to ensure audit readiness.
• Tracking & Analytics: Maintain rigorous tracking systems for enrollment, adverse events, and milestones while translating diagnostic performance metrics into clinical insights.

 
qualifications:

• Education: Bachelor's degree in a scientific field.
• Experience: Minimum 5 years of clinical operations experience (pharma, biotech, or medical device), with 1-2+ years of direct Clinical Project Manager experience preferred.
• Regulations & Systems: Deep knowledge of FDA, ICH/GCP, and global regulatory requirements (e.g., EU MDR); proficiency with EDC, CTMS, and eTMF systems.
• Technical Expertise: Understanding of arrhythmia/ECG interpretation, algorithm-based diagnostics, or AI/ML-driven medical devices.
• Attributes: Proactive, collaborative, self-driven leader with a "take-charge" attitude.

#LI-AO1

skills: Project Management, EDC (Electronic Data Capture), Good Clinical Practice (GCP), Food and Drug Administration (FDA), International Council for Harmonization (ICH), FDA Submissions


Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact View email address on randstadusa.com.


Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).


This posting is open for thirty (30) days.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.