Associate Director, Clinical Research
Core
Delivering committed parts of clinical interventional studies, managing staff resources, and ensuring compliance with ICH-GCP and local regulations.
Role type
Senior individual contributor clinical research manager (line management)
Builds
Clinical interventional studies
Domain
Life sciences / Clinical research
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Line management, resource planning, performance management, site qualification, study initiation and closure, compliance monitoring, coaching, project management, change management, negotiation, presentation
Preferred skills
Experience in Development Operations (CRA/SrCRA/LSAD), knowledge of eTMF systems, ability to work with Functional Service Providers
Technologies
eTMF systems
Responsibilities
Line manage Clinical Research Associates (CRAs) and Clinical Study Administrators (CSAs), ensure study sites are identified and qualified, review monitoring visit reports, perform accompanied site visits, prepare salary and bonus proposals for direct reports, ensure compliance with local policies and code of ethics, contribute to study process quality improvement
Seniority
Senior, hands-on IC with line management responsibilities