Senior Clinical Trial Manager (Contract)
Core
Senior Clinical Trial Manager overseeing Phase 3 multi-site clinical study operations for late-stage biotechnology products (retinal vascular diseases and cystic fibrosis), managing CROs, sites, and trial execution.
Role type
Senior IC clinical trial manager (contract)
Builds
Phase 3 clinical trials for 4D-150 (wet AMD, diabetic macular edema) and 4D-710 (cystic fibrosis)
Domain
Biotechnology / Ophthalmology / Genetic Medicine
Required skills
Clinical trial management, CRO oversight, Vendor management, Protocol execution, Risk mitigation, Regulatory compliance (ICH GCP), Clinical supply forecasting, TMF management, Cross-functional collaboration
Preferred skills
Ophthalmology experience, MS Project proficiency, Site monitoring experience
Technologies
MS Project, Microsoft Office Suite
Responsibilities
Manage protocol execution and oversee CRO/study service providers; Support establishment of study milestones and track metrics; Ensure compliance with ICH GCP and regulations; Prepare and review clinical trial documentation; Develop internal tracking tools; Manage Trial Master File (TMF); Coordinate audit resolution; Mitigate risks and manage issues; Support training of CRO staff and sites; Facilitate study start-up with CROs and sites; Assist data management with database lock and study reports; Respond to queries and monitoring discrepancies; Plan investigator meetings; Conduct or oversee clinical site and vendor monitoring visits; Track protocol deviations; Oversee clinical supply forecasting; Manage junior staff; Support SOP development; Travel to sites and conferences.
Seniority
Senior, hands-on IC