该职位来源于猎聘 JD The Study Start-up (SSU) Specialist functions as a subject matter expert on all SSU-related activities in the country/region, oversees and leads SSU activities in collaboration with other clinical research stakeholders and serves as a leader for local/global SSU process improvements and patient recruitment strategies. Responsibilities: Study Start-up Coordination and Execution: ? Coordinate guide and assist with all start up activities prior to site activation, including but not limited to: ? Site Informed Consent Form (ICF) localization and guidance in line with regulatory/health authority requirements ? Ethics Committee information, meeting dates & costs ? Ethics applications & associated online systems ? Ethics & Governance submission processes ? Clinical Trial Health Authority application and regulatory submission process ? Contracts & Indemnity request process ? For global studies, localize global Informed Consent Form (ICF) with country requirements ? Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentation. ? Review, analyze and collate metrics to ensure processes are in place that drive efficiency and reduction of timelines across start up and contracts negotiation. ? Ensure all start up information & requirements are kept up to date in a central repository for both global and local Study teams. ? Assist with label preparation and approval (local label representative) for studies in collaboration with local regulatory department. ? Track metrics and study start-up timelines to identify trends and opportunities for improvement. Relationship management: ? Liaise and collaborate with relevant authorities / bodies to further enhance clinical trial processes, government policies / laws, via innovative approaches. ? Maintain currency and awareness of changes in Start Up processes across government, hospital & industry & liaise with stakeholders to resolve any SSU issues. ? Proactively respond to information survey requests by government / industry bodies. ? Provide continuous and proactive communication with ECs / hospital administration / industry bodies to obtain accurate and up to date information on clinical trial status and activities. ? Maintain communication with local legal/regulatory/medical affairs departments to ensure input is sought and all internal/external requirements are met. ? Provide guidance to CSMs and CSS on regulatory/ethics, track & drive site activations by regular review and monitoring status of submissions/activations. ? In collaboration with vendor management and procurement, provide input as required into vendor identification, selection, and RFI/RFP process. ? Liaise and share best practices with other SSUS within the region/organization. New Site Identification: ? Assist with identification and tracking of new sites in collaboration with CSMs. Recruitment: ? Provide expertise and guidance to Global and/or Local Study Teams for identification, creation and implementation of specific recruitment/retention tactics & contingency planning. ? Initiate patient recruitment meetings with CSM and advise on study-specific recruitment & retention needs. ? Develop innovative patient recruitment/retention practices and share concepts with vendors as needed. ? Provide justification/recommendation of site closure in collaboration with CSM. ? Provide reports to study teams on overall site performance as required. Contracts/Budget: ? Negotiate contracts and study budgets with sites during the study start-up phase to ensure finalization. ? Provide local fee structures and budgetary advice as required and ensure compliance to Fair Market Value (FMV) in the country. ? Collaborate with CSMs to maintain data to ensure FMV. ? Liaise with management / CSMs to implement budget cost containment and implement contingencies as required. Requirement ? At least Bachelor degree of medical/pharmaceutical area ? Candidates has experience in feasibility, EC submission and contract negotiation ? English: Good reading and writing ? Nice communication skills ? At least about 1-year clinical experience