FSP Principal CTC
Core
Coordinate and facilitate clinical trial activities, oversee administration, and support site activation and feasibility for pharmaceutical and biotech projects.
Role type
Principal Clinical Trial Coordinator (Site Activation & Feasibility)
Builds
Clinical trial site networks and activation pipelines for global pharmaceutical and biotech projects
Domain
Clinical Research / Pharmaceutical Trials
Required skills
Site feasibility assessment, regulatory document review, (e)TMF management, site agreement negotiation, stakeholder liaison, process improvement, training delivery, data reconciliation, critical path planning, vendor management
Preferred skills
Therapeutic area expertise, strategic collaboration site inclusion, global strategic feasibility processes, system support (Activate & eTMF), local market knowledge
Technologies
(e)TMF, CTMS, Activate
Responsibilities
Coordinate assigned trial activities and ensure tasks are scheduled and fulfilled; Perform file reviews and maintain study documentation; Support site activation critical path and conduct feasibility visits; Train new personnel and provide technical support; Liaise with local affiliates and investigators to optimize site selection; Assist in negotiation of site agreements and budgets; Ensure audit readiness and regulatory compliance.
Seniority
Principal, hands-on IC with mentorship responsibilities