Clinical Project Manager

Apex Systems is a world class technology services business that incorporates industry or insights and experience to deliver solutions that fulfill our clients’ digital visions. Apex has an opportunity for an Clinical Project Manager. For applicants who are interested in this opportunity, send your updated resume to [email protected]. Here are the details: Position: Clinical Project ManagerLocation: Remote Project Duration: 12 monthsRate: Negotiable Based on Experience JOB DESCRIPTIONOpen to remote candidates based in Eastern Standard Time ZoneThe Clinical Project Manager is responsible for managing and executing medical device clinical investigations from contributing to study design through all phases of the clinical study (study initiation through closeout), ensuring operational excellence, inspection readiness, and compliance with applicable regulatory and quality requirements. This role leads cross-functional study execution, oversees CROs/vendors and sites, manages timelines and budgets, and ensures study deliverables support clinical evidence needs across the product lifecycle (e.g., premarket and post-market activities). The Clinical Project Manager may support other corporate initiatives, as required. Key Responsibilities Study Planning and Start-Up• 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. Study Execution and Oversight• 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. Quality, Compliance, and Inspection Readiness• 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. Data Review, Reporting, and Clinical Evidence Support• 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. Other• Perform other duties as required and support other tasks related to company-sponsored clinical studies. Education and Experience• 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).• 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.• Strong analytical skills, attention to detail, and interpersonal skills.• Knowledge of applicable agency guidelines and requirements. Skills/Competencies• 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.• Proficiency with standard PC applications (word processing, spreadsheets, databases) and comfort with clinical trial systems (e.g., EDC, eTMF) preferred.• Flexible and able to work in a fast-paced, cross-functional environment; collaborative team player. Travel RequirementsEstimated travel (domestic and international) is approximately 10% per year.

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