Specialist Study Start Up & Regulatory Affairs
Core
Manages study start-up and regulatory deliverables for clinical trials, serving as a liaison between project teams, authorities, vendors, and investigative sites.
Role type
Specialist Study Start Up & Regulatory Affairs
Builds
Clinical trial site activation and regulatory submissions
Domain
Pharmaceutical/CRO industry, rare disease and oncology
Deliverable
client delivery
Required skills
Study start-up management, regulatory document preparation and review, clinical site agreement negotiation, site outreach, ICH GCP compliance, document translation coordination, project tracking
Preferred skills
Experience with low-complexity projects, knowledge of national regulations
Technologies
Trial Master File (TMF), study portals
Responsibilities
Manage study start-up activities for low-complexity projects, prepare and review regulatory information for submissions, collect and track essential documents, draft and execute clinical site agreements, conduct site outreach, coordinate with study teams for site activation readiness, review documentation for compliance, arrange document translation, contribute to SSU strategy development, ensure timely completion of project trackers and TMF filings
Seniority
Mid-level Specialist
