Clinical Trial Manager, Class III Medical Devices

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee the daily execution and coordination of clinical trials for Class III medical devices.

• Monitor study activities, timelines, deliverables, and operational challenges in collaboration with cross-functional team members.

• Liaise with study sites, CROs, and external vendors to ensure that protocol-required activities adhere to timelines and quality standards.

• Track study advancement and operational metrics, recognizing risks and issues that may impact timelines and data integrity.

• Aid in vendor oversight and site management by evaluating performance and addressing operational quality concerns.

• Work in conjunction with Safety, Regulatory, Quality, and Data Management teams.

• Provide assistance with documentation, vendor oversight activities, and site management procedures.

• Enhance communication between internal team members, CROs, and study sites.

• Assist with regulatory submissions, protocol modifications, and safety reporting processes.

• Organize and monitor follow-up activities such as action item logs and issue tracking.

⛳️ Requirements

• Bachelor’s degree; an advanced degree is preferred.

• Minimum of 5 years of experience in clinical research or clinical operations.

• Proven experience supporting clinical trials for Class III implantable medical devices.

• Exceptional organizational and communication capabilities.

• Proficient in tracking study progress and identifying operational risks.

• Familiarity with regulatory and quality standards relevant to clinical trials.

• Experience in vendor oversight and site management.

• Knowledge of regulatory submissions and protocol amendments.

• Skilled in safety reporting workflows and managing study modifications.

🏝️ Benefits

• Medical, Dental, Vision, & Life insurances.

• Fitness & Wellness programs, including a fitness reimbursement.

• Short- and Long-Term Disability insurance.

• A minimum of 15 days of paid vacation along with additional end-of-year shutdown time off (Dec 26-Dec 31).

• Up to 12 company-paid holidays plus 3 paid days off for Personal Significance.

• 80 hours of sick leave per calendar year.

• Paid Maternity and Parental Leave benefits.

• Participation in a 401(k) program with company-matched contributions.

• Employee stock purchase plan.

• Tuition reimbursement of up to $10,000 per calendar year.

• Participation in Employee Resource Groups.

• Short-term and long-term incentives, including cash bonuses and equity incentive opportunities.