Clinical Project Manager
Core
Leading Local Study Teams at country level to deliver committed components of clinical studies according to agreed resources, budget and timelines, ensuring compliance with Sponsor Procedural Documents, ICH-GCP, and local regulations.
Role type
Senior Clinical Project Manager (Local Study Team Lead)
Builds
Clinical studies for life sciences sponsors
Domain
Clinical Research / Oncology / Respiratory
Required skills
Clinical Trial Phase III experience, Oncology or Respiratory therapeutic area knowledge, Clinical Study Process understanding, Project management, Site selection and qualification, Budget management, Team leadership, Risk management, Regulatory submission coordination
Preferred skills
Experience with CTMS and local websites, IT system adaptability, Travel flexibility
Technologies
CTMS, fSMA, MICF, ICF
Responsibilities
Lead Local Study Team (CRA/CSA), coordinate site selection and qualification, manage study budget and financial agreements, prepare local Master CSA and Informed Consent Forms, oversee monitoring activities, resolve complex study problems, organize team meetings
Seniority
Senior, hands-on IC