Clinical Project Manager

Dexian is a leading provider of staffing, IT, and workforce solutions with over 12,000 employees and 70 locations worldwide. They are seeking a Clinical Project Manager responsible for managing and executing medical device clinical investigations, ensuring operational excellence, compliance, and oversight of study execution.

Responsibilities:

• Lead study feasibility activities, including site identification/selection and investigator qualification support
• Support development/review of study documents (e.g., investigational plan/protocol, informed consent, monitoring plan, study manuals, case report form/input to EDC design)
• Coordinate and track start-up deliverables: vendor selection/oversight, contracts, IRB/EC submissions support, site activation, and study training
• Partner with Medical Affairs and Regulatory Affairs on clinical-related submission components (U.S. and international) to support study conduct and product clearance/approval activities
• Manage end-to-end operational oversight of study conduct across sites/vendors, including enrollment tracking, monitoring oversight, issue escalation, and resolution
• Oversee CRO and vendor performance to contracted deliverables, quality, and timelines; lead routine governance meetings and drive corrective actions as needed
• Monitor study progress against milestones, proactively identify risks, and implement mitigation plans to maintain timelines and data quality
• Lead cross-functional study communications, including status updates, dashboards/metrics, risk registers, and executive-ready summaries
• Ensure study activities are conducted in accordance with applicable regulations, GCP expectations, and internal SOPs
• Oversee maintenance and quality oversight of study documentation (e.g., TMF/eTMF completeness, traceability, and audit readiness)
• Track and support documentation of protocol deviations/noncompliance, including triage, follow-up, and CAPA inputs where applicable
• Coordinate with Quality/Medical Safety teams (as applicable) on safety/event processes, reconciliation activities, and trend monitoring
• Coordinate review of clinical data outputs, support data cleaning follow-up, and contribute to interpretation of clinical information with stakeholders
• Support development/review of study reports and clinical evidence deliverables (e.g., clinical study report inputs, summaries for regulatory documentation)
• Compile and summarize post-market clinical information to support regulatory documentation and lifecycle clinical evidence needs
• Collaborate cross-functionally on documentation for the Design History File (DHF) and for regulatory filings
• Perform other duties as required and support other tasks related to company-sponsored clinical studies

Requirements:

• B.S. or B.A. (preferably in a Life Science field) or an equivalent combination of education and experience
• 5+ years of medical device or drug-related clinical experience (minimum of 2 years of direct project management experience preferred)
• Strong analytical skills, attention to detail, and interpersonal skills
• Knowledge of applicable agency guidelines and requirements
• Strong operational project management skills; ability to drive execution across multiple workstreams and timelines
• Excellent written and verbal communication skills; able to communicate effectively across all levels of the organization
• Strong problem-solving and risk management mindset; able to escalate appropriately and drive resolution
• Flexible and able to work in a fast-paced, cross-functional environment; collaborative team player
• Experience managing CROs/vendors and multi-site clinical studies preferred
• Experience with device clinical investigations and IRB/EC processes; IDE experience a plus
• Endocrinology/diabetes experience highly desired
• Proficiency with standard PC applications (word processing, spreadsheets, databases) and comfort with clinical trial systems (e.g., EDC, eTMF) preferred