Medical Project Coord
Core
Coordinate and review safety data, monitor clinical trial status, and support drug safety operations to ensure regulatory compliance and patient safety.
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
Life Sciences / Clinical Research / Pharmacovigilance
Required skills
Safety data review and trending, GCP knowledge, SAE processing, clinical safety experience, problem solving, data management knowledge, biostatistics working knowledge
Preferred skills
Clinical research monitoring, pharmacovigilance, safety data coding, mentoring
Technologies
Line listings, company dashboards, visualization tools, computer software
Responsibilities
Coordinate and review safety data for trends and coding consistencies, review designated sections of aggregate reports, help create/review safety and medical management plans, monitor data review status and escalate risks, present at business development and investigator meetings, assist in training and mentoring.
Seniority
Mid-level, hands-on IC