Clinical Project Manager

Advantage Technical is a company focused on overseeing clinical investigations for medical devices. The Clinical Project Manager will be responsible for the planning, execution, and completion of clinical studies, ensuring compliance and quality throughout the process.

Responsibilities:

• Lead feasibility assessments, including site identification, site qualification, and investigator support
• Contribute to the development and review of key study documents such as protocols, informed consent forms, monitoring plans, study manuals, and CRFs/EDC specifications
• Coordinate and track all start‑up activities: vendor selection and oversight, contract execution, IRB/EC submissions, site activation, and study training
• Partner with Medical Affairs and Regulatory Affairs on U.S. and international submission components supporting study conduct and product approvals
• Manage day‑to‑day operational execution across sites and vendors, including enrollment tracking, monitoring oversight, and issue escalation/resolution
• Oversee CRO and vendor performance to ensure adherence to timelines, quality expectations, and contractual deliverables; lead governance meetings and corrective action planning
• Monitor progress against study milestones, identify risks proactively, and implement mitigation strategies to maintain timelines and data integrity
• Lead cross‑functional communication through status updates, dashboards, risk registers, and executive‑level summaries
• Ensure all study activities comply with applicable regulations, GCP, and internal SOPs
• Oversee maintenance and quality of study documentation, ensuring TMF/eTMF completeness, traceability, and audit readiness
• Track and support documentation of protocol deviations and noncompliance, including triage, follow‑up, and CAPA contributions
• Collaborate with Quality and Medical Safety teams on safety reporting, reconciliation, and trend monitoring
• Coordinate review of clinical data outputs, support data cleaning activities, and contribute to interpretation of clinical findings
• Support development and review of study reports and clinical evidence deliverables, including inputs to clinical study reports and regulatory documentation
• Compile and summarize post‑market clinical information to support regulatory submissions and lifecycle evidence needs
• Partner cross‑functionally on documentation for the Design History File (DHF) and regulatory filings
• Perform other duties as assigned in support of company‑sponsored clinical studies

Requirements:

• Bachelor's degree (Life Sciences preferred) or equivalent combination of education and experience
• 5+ years of clinical research experience in medical devices or pharmaceuticals; at least 2 years of direct project management preferred
• Strong analytical, interpersonal, and detail‑oriented skill set
• Knowledge of relevant regulatory guidelines and requirements
• Strong operational project management capabilities with the ability to drive multiple workstreams
• Excellent written and verbal communication skills across all organizational levels
• Effective problem‑solving and risk‑management mindset with appropriate escalation judgment
• Experience managing CROs/vendors and multi‑site clinical studies preferred
• Experience with device clinical investigations and IRB/EC processes; IDE experience is a plus
• Endocrinology/diabetes experience strongly preferred
• Proficiency with standard PC applications and familiarity with clinical trial systems (EDC, eTMF) preferred