Clinical Program Manager - Medical Devices
Posted 2026-05-06
Remote, USA
Full-time
Immediate Start
- *Job Title : Clinical Project Manager
- *Location : Remote
- *Pay range : $70 - $73/hour
- *Contract : 1 year
- Clinical Project Manager
- (Medical Device Clinical Studies)
- *Position Summary
- *The Clinical Project Manager is responsible for leading and executing medical device clinical investigations across the full study lifecycle—from study design and start-up through closeout and reporting. This role ensures operational excellence, regulatory compliance, inspection readiness, and high-quality clinical data generation to support product development, regulatory submissions, and post-market clinical evidence needs.
- *The Clinical Project Manager leads cross-functional teams, oversees CROs and vendors, manages timelines and budgets, and drives study execution to meet strategic and regulatory objectives.
- *Key Responsibilities
- *Study Planning & Start-Up
- Lead study feasibility activities, including site identification, qualification, and selection.
- Contribute to the development and review of study documentation (e.g., investigational plan/protocol, informed consent forms, monitoring plans, study manuals, CRFs, EDC inputs).
- Coordinate start-up deliverables including vendor selection and oversight, contract support, IRB/EC submissions, site activation, and investigator training.
- Partner with Medical Affairs and Regulatory Affairs to support clinical sections of U.S. and international regulatory submissions.
- *Study Execution & Oversight
- Provide end-to-end operational oversight of multi-site clinical studies.
- Manage CROs and vendors to ensure adherence to scope, quality, timelines, and budget.
- Track enrollment, milestones, and deliverables; proactively identify risks and implement mitigation strategies.
- Lead governance meetings and cross-functional communications.
- Prepare dashboards, study updates, risk registers, and executive-level summaries.
- *Quality, Compliance & Inspection Readiness
- Ensure studies are conducted in accordance with GCP, applicable regulatory requirements, and internal SOPs.
- Oversee TMF/eTMF completeness, documentation quality, and audit/inspection readiness.
- Track protocol deviations and noncompliance events; support investigations and CAPA development as needed.
- Coordinate with Quality and Medical Safety teams regarding safety reporting, reconciliation, and trend monitoring.
- *Data Review & Clinical Evidence Support
- Coordinate review of clinical data outputs and support data cleaning activities.
- Contribute to interpretation of clinical data with internal stakeholders.
- Support development and review of clinical study reports (CSRs) and regulatory documentation.
- Compile post-market clinical information to support lifecycle management and regulatory submissions.
- Collaborate on documentation for the Design History File (DHF) and other regulatory filings.
- *Additional Responsibilities
- Support corporate clinical initiatives and other company-sponsored clinical activities as required.
- *Qualifications
- *Education
- Bachelor’s degree in Life Sciences or related field (or equivalent combination of education and experience).
- *Experience
- 5+ years of clinical research experience in medical devices or pharmaceuticals.
- Minimum 2+ years of direct project management experience preferred.
- Experience managing CROs, vendors, and multi-site clinical studies.
- Experience with medical device clinical investigations and IRB/EC processes required; IDE experience preferred.
- Experience in endocrinology or diabetes is highly desirable.
- *Skills & Competencies
- Strong operational project management skills with the ability to drive execution across multiple workstreams.
- Solid understanding of GCP, regulatory guidelines, and quality requirements.
- Proven risk management and problem-solving capabilities.
- Excellent written and verbal communication skills; able to effectively engage stakeholders at all levels.
- Strong analytical skills and attention to detail.
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