Clinical Operations Manager

Skills Alliance; United States; Remote; USD 55,104 - 82,656; Part time

Benefits offered by this job

Part-time flexibility

Direct involvement in life-changing technology

Work with a skilled team

Competitive hourly rate

Job summary

A growing medical device startup in the United States seeks a part-time Clinical Operations Manager to oversee early-stage clinical trial activities. This role involves managing day-to-day operations, ensuring compliance with regulations, and supporting U.S. clinical trial execution. The ideal candidate has over 5 years of experience in clinical operations and is capable of working independently in a remote environment. Competitive hourly rate offered.

Qualifications

• 5+ years of experience in clinical operations within medical device or biotech.
• Prior experience with cardiovascular or structural heart trials preferred.
• Strong understanding of FDA regulations and clinical trial management.

Responsibilities

• Manage day-to-day clinical trial activities ensuring compliance.
• Support site selection, study start-up, and investigator engagement.
• Coordinate communication among internal teams and clinical sites.
• Assist with trial documentation and regulatory submissions.

Skills

Clinical operations

FDA regulations

GCP compliance

Problem-solving

Communication

Organization

Job description

Clinical Operations Manager – Medical Device Startup

Location: United States (Remote)

Industry: Medical Devices / Structural Heart / Cardiovascular

Job Type: Part-Time

About Us

We’re an early-stage medical device company focused on developing a novel transcatheter solution for the treatment of mitral valve regurgitation. Backed by leading VCs in the MedTech space, our team is rapidly growing as we move through preclinical and early clinical stages. We’re seeking a part-time Clinical Operations Manager to support our U.S. clinical trial execution and operations strategy.

Responsibilities

As the Part-Time Clinical Operations Manager, you will play a critical role in supporting and overseeing early-stage clinical trial activities in the U.S. Your responsibilities will include:

• Managing day-to-day clinical trial activities and ensuring compliance with GCP, FDA, and institutional guidelines
• Supporting site selection, study start-up, and investigator engagement
• Coordinating communication among internal teams, external partners, and clinical sites
• Assisting with trial documentation, data collection oversight, regulatory submissions, and budget tracking
• Providing operational support for U.S.-based clinical studies, including occasional on-site monitoring and investigator meetings

Qualifications

• 5+ years of experience in clinical operations within the medical device or biotech industry
• Prior experience supporting cardiovascular or structural heart trials preferred
• Strong understanding of FDA regulations, GCP, and clinical trial management
• Excellent communication, organization, and problem‑solving skills
• Ability to work independently in a remote, startup environment
• Willingness to travel domestically up to 50%

Benefits

• Part‑time flexibility with potential to grow as the company scales
• Direct involvement in life‑changing cardiovascular technology
• Work alongside a highly skilled, mission‑driven team
• Competitive hourly rate and opportunity for longer‑term engagement

How to Apply

If you’re a clinical operations professional passionate about advancing next‑generation cardiac technologies, we’d love to hear from you.