Clinical Program Manager - Medical Devices

• *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. • <