Clinical Project Manager

NEW OPPORTUNITY - SNR MANAGER, CLINICAL PROJECT MANAGEMENT, SMALL MED DEVICE

The Senior Clinical Project Manager (CPM) will lead the planning, execution, and management of clinical studies to support regulatory submissions, product development, and post-market surveillance. This role is ideal for someone who thrives in a small-company environment and is comfortable working both strategically and tactically across multiple projects.

Key Responsibilities

• Lead and manage all aspects of clinical trials (feasibility, site selection, startup, monitoring, closeout) in compliance with GCP, ICH guidelines, and regulatory requirements.

• Develop and maintain clinical project plans, timelines, budgets, and risk mitigation strategies.

• Act as primary liaison between the company and CROs, vendors, investigators, and study sites.

• Author, review, and manage clinical study documentation including protocols, ICFs, monitoring plans, CRFs, and final reports.

• Oversee clinical trial operations including data collection, site monitoring, and vendor performance.

• Collaborate cross-functionally with Regulatory, Quality, R&D, and Marketing to align clinical activities with business goals.

• Ensure timely and accurate reporting of study status, milestones, and metrics to leadership.

• Participate in regulatory submissions (IDE, PMA, 510(k), CE Mark) as clinical lead.

• Support clinical strategy development and contribute to scientific publications and presentations.

• Mentor junior clinical staff and help build scalable clinical processes.

Qualifications

• Bachelor’s degree in life sciences, nursing, or a related field (Master’s or RN preferred).

• Minimum 7+ years of experience in clinical research, with at least 3 years managing clinical trials for medical devices.

• Strong knowledge of FDA and international medical device regulations and GCP/ICH guidelines.

• Demonstrated ability to manage multiple complex studies independently.

• Experience working with CROs, vendors, and clinical sites globally.

• Excellent communication, organizational, and leadership skills.

• Comfortable working in a fast-paced, entrepreneurial environment with shifting priorities.

Nice to Have:

• Experience with Class II/III devices or combination products.
• Previous involvement in regulatory submissions (e.g., IDE, 510(k), PMA).
• Proficiency with EDC systems and clinical trial management systems (CTMS).
• Experience in startup or small company settings.

Reach out now - active interviews:

tbacchus@barringtonjames.com