西安招聘

工作职责:

岗位职责:

Main Responsibilities and Accountabilities:

Study Start-up Coordination and Execution:

? Coordinate guide and assist with all start up activities prior to site activation, including but not limited to:

o Site Informed Consent Form (ICF) localization and guidance in line with regulatory/health authority requirements.

o Ethics Committee information, meeting dates & costs.

o Ethics applications & associated online systems.

o Ethics & Governance submission processes.

o Clinical Trial Health Authority application and regulatory submission process.

o Contracts & Indemnity request process.

o For global studies, localize global Informed Consent Form (ICF) with country requirements.

o Local sample application and permit submission processes.

? 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/clinical operation 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 SSU within the region/organization.

New Site Identification:

? Assist with identification and tracking of new sites in collaboration with CSMs.

? Perform/coordinate site level feasibility activities including evaluation of patient population and final site selection.

Recruitment:

? Provide expertise and guidance to Global and/or Local Study Team (LST) 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 local 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 / Country Study Managers (CSM) to implement budget cost containment and implement contingencies as required.

任职资格:

Qualifications:

? University Degree or Equivalent preferably in a medical/science-related field. ? Prior work experience demonstrating knowledge and understanding of clinical trials, such as that obtained in a clinical trial monitor capacity, and experience managing projects.

? Demonstrated knowledge and understanding of ICH-GCP, the regulatory, ethics and contractual requirements for starting clinical trials in relevant country.

泰格医药是行业领先的一体化生物医药研发服务平台，为全球制药和医疗器械行业提供跨越全周期的临床研究创新解决方案。通过全面的服务体系和***的质量标准，我们助力生物医药产业提升研发效率、降低研发风险，确保研究项目高质量交付，加速医药产品市场化进程，履行对行业和患者的承诺。同时，我们也通过覆盖各领域的80多家子公司，打造赋能全产业链的创新生态，推动医疗产业创新和发展。作为全球化的研发平台，泰格医药在全球布局170多个办事处和研发基地，拥有超过8600人的专业团队，覆盖5大洲的51个国家，致力于解决最具挑战的全球健康问题，满足患者的未尽医疗需求，创造社会价值，造福人类健康。