该职位来源于猎聘 Study Start-Up Specialist Executes all start-up activities prior to site activation on assigned studies, according to company standards and aligned with study / project requirements and timelines. Prepares country level Informed Consent Form(ICF) and obtains ethics committees' and local regulatory authorities' approval. Prepares ongoing submissions, amendments and periodic notifications required by ethics committees and regulatory authorities as needed within the country. Maintains and analyzes study start-up data(metrics) on assigned studies, ensuring optimal efficiency to reduce start-up timelines and identify opportunities for continuous improvement. Partners with Clinical Study Managers(CSMs) to provide guidance on regulatory / ethics requirements, to track and drive site activations and trial amendments submissions, by regulatory reviewing and monitoring status of submissions / activations. Supports drug label preparation and approval (as local label representative) for studies in collaboration with local Regulatory / Quality department, as required.
Liaises and collaborates with relevant authorities / bodies to further enhance clinical trial process, government policies / laws, via innovative approaches. Submits, according to local regulatory requirements, all Suspected Unexpected Serious Adverse Reactions (SUSARs), Six Monthly SUSAR Reports (SSRs) and Development Safety Update Reports (DSURs). In collaboration with CSMs, identifies and tracks new investigator sites performing feasibility, as applicable, and develops and supports effective patient recruitment and retention practices, as required. Responsible for study budget and contracts negotiation in collaboration with Contracts Manager/ Associate, as required and ensures compliance with Fair Market Value (FMV) in the country.