Senior Clinical Project Manager

Clinnect; United States; Remote; USD 96,000 - 165,000; Full time

Job summary

Clinnect is seeking a Senior Clinical Project Manager to lead planning, execution, and oversight of medical device clinical programs. You will manage timelines, budgets, vendor oversight, site management, risk mitigation, and regulatory compliance in a fast-paced development environment.

This fully remote 12-month renewable contract favors candidates in EST/CST time zones. The role requires hands-on experience with IDE, post-market, ICH-GCP, ISO 14155, and working with cross-functional teams

Qualifications

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, Healthcare, or related discipline.
• 5+ years of clinical operations or clinical project management in medical device, biotech, pharma, or CRO.
• Direct experience managing medical device clinical trials (IDE, post-market, observational, or registry-based).
• Strong understanding of FDA regulations, ICH‑GCP, ISO 14155, global clinical research requirements.

Responsibilities

• Lead operational execution of domestic and global medical device clinical studies from start-up to closeout.
• Develop and manage study timelines, budgets, forecasts, and resource plans.
• Oversee CROs, vendors, core laboratories, and external partners.
• Monitor enrollment progress, data quality, and operational metrics; address risks.
• Ensure trial conduct complies with regulations and quality systems.

Skills

Leadership

Communication

Stakeholder management

Travel willingness

Problem solving

Education

Bachelor's degree in Life Sciences or related

Advanced degree (MS, MPH, RN, PharmD)

Tools

EDC systems

CTMS platforms

Job description

The Senior Clinical Project Manager (CPM) will lead the planning, execution, and oversight of clinical research programs supporting innovative medical devices. This role is responsible for managing all aspects of clinical study operations, including study timelines, budgets, vendor oversight, site management, risk mitigation, and regulatory compliance. The ideal candidate brings hands-on experience managing medical device clinical trials and thrives in a fast-paced development environment.

This is a fully remote, 12-month renewable contract opportunity expected to be a long-term and on-going engagement. Candidates located in EST and CST are preferred at this time.

Key Responsibilities

• Lead the operational execution of domestic and global medical device clinical studies from study start-up through closeout.
• Develop and manage study timelines, budgets, forecasts, and resource plans to ensure successful trial execution.
• Serve as the primary operational lead for assigned clinical programs, driving cross-functional collaboration and accountability.
• Oversee study start-up activities, including site selection, qualification, activation, contracting, and enrollment planning.
• Manage relationships with CROs, vendors, core laboratories, and other external partners.
• Monitor study performance, enrollment progress, data quality, and operational metrics, proactively addressing risks and challenges.
• Ensure trial conduct is compliant with applicable regulations, GCP, company procedures, and quality system requirements.
• Support the development and review of protocols, informed consent documents, monitoring plans, study manuals, and other essential clinical trial documentation.
• Partner with clinical, regulatory, quality, biostatistics, data management, and medical affairs teams to support program objectives.
• Lead study team meetings and provide regular status updates to executive leadership.
• Oversee budget tracking, accruals, forecasting, and financial reconciliation activities.
• Drive inspection readiness across all study activities and ensure appropriate documentation is maintained throughout the trial lifecycle.
• Support investigator meetings, site training, and ongoing site engagement activities.
• Identify and implement process improvements to enhance study execution and operational efficiency.
• Mentor junior clinical operations team members and contribute to the development of departmental best practices.

Required Qualifications

• Bachelor's degree in Life Sciences, Nursing, Biomedical Engineering, Healthcare, or a related discipline.
• 5+ years of clinical operations or clinical project management experience within the medical device, biotechnology, pharmaceutical, or CRO industry.
• Direct experience managing medical device clinical trials, including IDE, post-market, observational, or registry-based studies.
• Strong understanding of FDA regulations, ICH‑GCP, ISO 14155, and applicable global clinical research requirements.
• Experience overseeing CROs, vendors, clinical sites, and cross-functional study teams.
• Demonstrated success managing study budgets, timelines, deliverables, and study risks.
• Strong leadership, communication, and stakeholder management skills.
• Experience working with EDC systems, CTMS platforms, and clinical trial documentation.
• Ability to influence without direct authority and effectively manage competing priorities.
• Willingness to travel as needed for investigator meetings, site visits, and study oversight activities.

Preferred Qualifications

• Advanced degree (MS, MPH, RN, PharmD, or equivalent).
• Experience working for a medical device manufacturer or sponsor organization.
• Experience supporting pivotal, PMA, De Novo, or global regulatory studies.
• Clinical Research certification (ACRP, SOCRA, PMP, or equivalent).