Local Study Associate Director
Core
Lead Local Study Teams at country level to deliver clinical study components, manage site lifecycle, and ensure compliance with ICH-GCP and local regulations.
Role type
Senior IC clinical study operations lead (country level)
Builds
Clinical trials for life sciences and healthcare industries
Domain
Clinical research / Life sciences
Deliverable
client delivery
Required skills
Clinical study process management, site selection and qualification, budget and financial management, risk management, project management, therapeutic area knowledge (Oncology, Rare Diseases, cardiology, hematology, CVRM), drug development process understanding, study drug handling, data management process understanding, cross-functional team leadership
Preferred skills
Experience in Medical Affairs-led or Academic-led studies, knowledge of international guidelines ICH GCP, ability to travel nationally and internationally
Technologies
CTMS, eTMF
Responsibilities
Lead Local Study Team consisting of CRA(s) and CSA(s), coordinate site selection and qualification, 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 study drug activities, plan and lead National Investigator meetings, coordinate audits and regulatory inspections, contribute to patient recruitment strategy, provide input to process development and improvement
Seniority
Senior, hands-on IC
