Associate 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.
Role type
Associate Clinical Project Manager (Sponsor dedicated)
Builds
Clinical studies for life sciences sponsors
Domain
Clinical research / Life sciences
Required skills
Clinical Trial Phase III experience, Oncology or Respiratory therapeutic area knowledge, Clinical Study Process understanding, Project management, Site selection and qualification, Regulatory submission coordination, Budget management, Team leadership, Risk management, IT systems adaptation
Preferred skills
None stated
Technologies
CTMS, local websites
Responsibilities
Lead Local Study Team consisting of CRA(s), CSA(s); Ensure compliance with Sponsor Procedural Documents, ICH-GCP and local regulations; Coordinate site selection and qualification; Prepare financial Study Management Agreement and local Master CSA; Prepare country level Master Informed Consent Form; Collect trial essential documents; Plan and coordinate local drug activities; Set up and maintain study in CTMS; Oversee and coordinate monitoring activities; Review monitoring visit reports; Identify risks and resolve complex study problems; Organize Local Study Team meetings
Seniority
Associate, hands-on IC
