Senior Clinical Project Manager

BioBoston Consulting is seeking an experienced Senior Clinical Project Manager / Clinical Operations Lead to support an active diagnostics/IVD clinical study. The role focuses on study organization, timeline and deliverable management, site and vendor coordination, documentation, sample-related workflows, and clinical operations oversight in a regulated environment.

Responsibilities:

• Provide day-to-day clinical project management support for an active IVD / diagnostic clinical study
• Bring organization, structure, and control to study activities
• Track study timelines, milestones, deliverables, action items, and open issues
• Coordinate with internal clinical, regulatory, quality, scientific, and operational stakeholders
• Support communication and follow-up with clinical sites, vendors, laboratories, and external partners
• Help manage site and sample-related study workflows
• Support EDC implementation/use and ensure study data/documentation activities remain organized
• Maintain or support study trackers, meeting minutes, issue logs, escalation logs, and project plans
• Support monitoring oversight, site follow-up, and documentation readiness as needed
• Identify risks, delays, gaps, or resource needs and help drive practical solutions
• Support TMF / clinical study documentation organization and inspection readiness
• Work independently and proactively in a small-company environment

Requirements:

• • Senior clinical project management or clinical operations experience
• • Experience with regulated clinical studies and GCP expectations
• • Familiarity with EDC systems and clinical study documentation
• • Experience coordinating clinical sites, vendors, CROs, laboratories, and internal teams
• • Strong timeline, issue, action-item, and deliverable tracking skills
• • Ability to work independently and bring structure to an active study
• • Strong communication skills and practical, hands-on execution style
• • The study involves multiple sites and sample-related workflows, so experience with diagnostics, IVD, medical device, sample collection, laboratory-related clinical studies, or infectious disease clinical studies is highly preferred
• • Direct experience with IVD, diagnostics, medical device, or sample-collection clinical studies strongly preferred
• • Experience with infectious disease, laboratory testing, biomarker, or diagnostic workflows is a plus
• • ISO 20916 or ISO 14155 exposure is a plus