ACTM
Core
Accountable for achieving final clinical deliverables (clean data) within contract timeframes for low to moderate complexity studies.
Role type
Clinical Team Manager (CTM)
Builds
Clinical trial operational and quality deliverables for customers
Domain
Clinical research / Life sciences
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
Clinical monitoring, ICH GCP compliance, resource management, financial acumen, regulatory submissions, team leadership, project tracking, document quality review
Preferred skills
Clinical Study Manager (CSM) experience, accompanied field visits, bid defense preparation
Technologies
Outlook, Excel, Word, tracking and management tools
Responsibilities
Manage clinical operational and quality aspects of allocated studies; Develop clinical tools and Trial Master File sections; Coordinate start-up activities and regulatory submissions; Monitor clinical trials and manage CRF collection/query resolution; Lead team meetings and implement standardized monitoring processes; Connect with study sites regarding protocol and patient participation issues.
Seniority
Mid-level, hands-on IC with team management