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 (Local Study Lead)
Builds
Clinical studies for life sciences sponsors
Domain
Clinical Research / Life Sciences
Deliverable
client delivery
Required skills
Clinical Trial Phase III experience, Oncology or Respiratory therapeutic area knowledge, site selection and qualification, regulatory submission coordination, budget management, cross-functional team leadership, risk management, IT system proficiency
Preferred skills
None stated
Technologies
CTMS, local websites
Responsibilities
Lead Local Study Team consisting of CRA(s) and CSA(s), coordinate site selection and qualification, ensure timely submission of documents to EC/IRB and Regulatory Authorities, prepare country financial Study Management Agreement and local Master CSA, prepare country level Master Informed Consent Form, oversee monitoring activities from activation to closure, manage local drug activities, set up and maintain study in CTMS, organize Local Study Team meetings
Seniority
Associate, hands-on IC
