Medical Project Coordinator
Core
Coordinate and review safety data, monitor clinical trial safety trends, and ensure compliance with regulatory standards to support drug safety operations.
Role type
Medical Project Coordinator (Clinical Safety)
Builds
Safety data reviews, safety review meeting summations, aggregate report sections, safety/medical management plans, and project implementation metrics.
Domain
Pharmaceutical/Clinical Research / Pharmacovigilance
Deliverable
client delivery
Required skills
Safety data review and trending, GCP knowledge, SAE processing, drug development safety reporting, biostatistics working knowledge, data management, clinical procedures, problem solving, critical thinking
Preferred skills
Training and mentoring, business development presentation, strategy call participation
Technologies
Line listings, company dashboards, visualization tools, computer software
Responsibilities
Review safety data for trends and coding consistencies, provide summations for safety review meetings, review designated sections of aggregate reports, help create/review safety and medical management plans, manage routine project implementation and budget considerations, monitor data review status and escalate risks, present at business development and investigator meetings, serve as primary point of contact for project teams
Seniority
Mid-level, hands-on IC