• *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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