Clinical Team Manager
Core
Functional Lead for Clinical Operations managing assigned countries, sites, and Clinical Research Associates (CRAs) to ensure study execution, risk mitigation, and quality compliance.
Role type
Senior Clinical Team Manager (IC)
Builds
Clinical trial operations for rare disease and oncology studies
Domain
Clinical Research / Life Sciences
Required skills
Clinical trial management, CRA oversight, risk mitigation, protocol deviation handling, site activation, TMF management, vendor contracting, audit preparation, corrective/preventative action planning, cross-functional collaboration, mentoring
Preferred skills
Experience in multiple regions, diverse therapeutic area expertise, ability to mentor/train staff
Technologies
Clinical Monitoring Plan (CMP), Site Management Plan, TMF, Fling Plan, SOPs
Responsibilities
Develop and review study documents (CMP, site visit templates, operating manuals), manage CRA assignments and site visit schedules, oversee site initiations and trial material supplies, monitor KPIs (recruitment, query resolution, SDA), review site visit reports and data listings, manage protocol deviations and non-compliances, coordinate audit preparations, support trial close-out, collaborate on patient recruitment plans, develop and update SOPs.
Seniority
Senior, hands-on IC
