CTC-L II
Core
Provides administrative and technical support to clinical trial project teams, ensuring audit readiness, site activation coordination, and document management.
Role type
Administrative and Technical Support Specialist (Clinical Trials)
Builds
Clinical trial site activation plans, Investigator Site Files (ISF), and regulatory documentation packages.
Domain
Clinical Research / Clinical Trials Management
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project coordination, document review and processing, regulatory guideline knowledge, data analysis, system database management, risk escalation, vendor tracking, stakeholder liaison
Preferred skills
Bachelor's degree, clinical trial database system proficiency, local language proficiency
Technologies
Activate, eTMF, MS Office (Word, Excel, PowerPoint), clinical trial database systems
Responsibilities
Coordinate and oversee assigned trial activities per task matrix; perform department, internal, country, and investigator file reviews; ensure tasks are completed on time, within budget, and to high quality; provide system support for Activate & eTMF; process and distribute documents to Client (e)TMF; assist with coordination of Investigator Site File (ISF) and Pharmacy binder materials; liaise with Global Investigator Services to resolve queries; maintain vendor trackers and study-specific documentation systems.
Seniority
Entry-level to Junior, hands-on IC