Senior Project Manager (French Speaking)
Core
Leading and overseeing the setup, implementation, and management of Post Approval Named Patient Programs (PA-NPP) and related clinical research projects.
Role type
Senior Project Manager (Clinical Research)
Builds
Post Approval Named Patient Programs (PA-NPP) and related clinical research projects
Domain
Clinical Research / Healthcare
Deliverable
client delivery
Required skills
Project management, risk management, team leadership, regulatory compliance (FDA, GDPR, GCP/ICH), eTMF and CTMS proficiency, change order management, study-specific training development
Preferred skills
Health or science degree, experience in CRO or research-related organization
Technologies
Microsoft Office, eTMF, CTMS, electronic data capture
Responsibilities
Lead regional and global PA-NPP projects ensuring timeline and budget compliance; manage project team leadership and operational oversight; build and maintain client relationships; identify and mitigate project risks; develop and document study-specific training requirements; prepare and finalize Out of Scopes (OOS) and change orders; review documentation for the Electronic Trial Master File (eTMF); update internal SOPs and processes; provide operational oversight including site visit audits and eTMF/CTMS compilation; maintain knowledge of global regulations and GCP/ICH Guidelines.
Seniority
Senior, hands-on IC with potential line management responsibilities