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Position: (Medical) SPM/AD工作职责
1.在部门负责人主导和指导下：与医学信息、医学事务、临床法规等团队共同制定项目全局策略、临床开发路径；
2.在策略和研究路径确定后，根据项目特点，在部门负责人的指导下，主导与临床药理、生物统计等团队完成不同阶段研究方案设计，并撰写方案摘要；
3.在运营团队、医学事务团队协助下，筛选并确定研究PI;
4.参与制定项目推进的总体KPI;
5.参与临床项目启动会，在部门负责人的指导下与PI就临床方案和医学问题进行充分沟通；
6.在项目实施过程中，在部门负责人的指导下进行受试者入组合格性审核；
7.在项目实施过程中，与药物警戒部门合作，对不良事件进行医学审核，并提出医学建议，以确保在整个临床试验过程中受试者的用药安全；
8.时刻掌握临床试验进展，动态分析临床数据，关注安全与疗效数据，对临床策略的调整和优化提出建议，并撰写方案修订摘要；
9.在项目结束阶段，深入分析临床数据特征，提炼项目的差异化优势，并根据政策法规的变化，竞品开发策略和临床数据，结合PI的意见，制定后续的临床开发策略和路径、上市策略；
10.指导医学专员撰写学术论文，参加国内外学术相关会议并做学术报告；
11.负责下属医学专员的KPI设定和绩效考核。
任职资格
1.临床医学硕士或以上学历，制药行业4-5年及以上临床药物研究经验;
2.对于肿瘤领域的临床知识有深入认识，尤其各种实体肿瘤（特别是非小细胞肺癌及脑癌）等；
3.熟悉国内外药物研发法规政策及临床研发现状；
4.精通临床试验全过程，具备生物学机制、药学、药理学等基本认知，具有将临床研究与非临床研究衔接的能力；
5.具有高度清晰的书面和口头表达能力，善于进行活跃而积极地沟通；
6.具有优秀的问题解决能力及应急预案管理能力，具备的专业知识、技巧、执业资格、语言能力、专业能力、必须通过的培训及考核等；
7.具有独立工作能力，良好的团队合作意识和执行力，理解并认同公司文化及理念，爱岗敬业，诚实正直。
8.熟练运用各类办公软件，具备良好的中、英文医学资料查询、分析总结、撰写能力。 -
Job Description – Clinical Project Manager (US)Responsibilities Will include:
• Oversee performance of CROs, third party vendors, and field CRAs including monitoring, to ensure compliance with study protocol and in accordance with scope of work andinaccordance with corporate timelines; identify areas of concern and escalate to CMO or CRO as appropriate.
• Develop and administer study budgets.
• Resolve patient eligibility and protocol deviation issues.
• Assist in preparing Clinical Study Reports and annual safety reports.
• Review monitoring reports for accuracy,completeness and conformance with SOPs.
• Maintains frequent contact with and work effectively with investigators and coordinators.
• Provides guidance, clinical trial management expertise, and direction to contract CRAs in the field and in-house staff.
• May monitor/audit clinical sites for adherence to protocol and GCP, including: conducting site pre-qualification, initiation, monitoring visits, and close-out visits or co-monitoring visits conducted by CRO personnel.
• Track items related to CDAs, budget and contract completion status.
• Assurance of regulatory compliance of investigational sites with company SOPs, EMA/FDA and ICH guidelines.
• Perform clinical data review of data listings and summary tables, including query generation.
• Review and/or submission of research ethics committee/regulatory documentation. ? Identify, select, and monitor performance of investigational sites for clinical studies; prepare accurate and timely visit reports from all site interaction visits.
• Develop and maintain good working relationships with investigators and study staff. ? Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
• Assist with establishing and tracking clinical timelines and appropriate performance metrics.
• Review key study quality metrics (e.g., eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team (autonomy may vary with experience).
• Investigate queries, monitor discrepancies as applicable.
• Manage/oversee investigational product (IP) accountability and reconciliation process.
• Responsible for review or approval of IP release packages.
• Negotiate and manage the contracts, budgets and payments for third party vendors, including CROs. Work closely with our accountants to accurately track spend and monitor cash flow forecast for clinical plan delivery.
You will also help us run our clinical organisation in an efficient and effective way by
• Carrying out background research and present findings.
• Producing documents, briefing papers, reports and presentations.
• Write or contribute to preparation of clinical protocols, assessments, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents.
• Perform initial review of CRO and other third party study vendor invoices to ensure that work is performed in accordance with scope of work.
• Assist with CRA and third party vendor training on protocols and practices.
• Assist in identification and hiring of appropriate CROs and third party study vendors. ? Provide study-specific outsourcing specifications for RFP's.
• Oversee or perform feasibility assessment for new clinical protocols.
• Identify, recruit and approve clinical investigators ensuring that study requirements can be met by these potential investigators/centres.
• Prepare and/or approve the design, format and content of CRF's, study procedure manuals and subject instructions.
• Oversee activities associated with clinical site start-up and ensure the collection and maintenance of essential documents for the TMF to ensure GCP compliance.
• Ensure appropriateness of forecast for investigational product and manage the overall investigational product accountability and reconciliation process.
• Manage Investigator meetings.
• Review and resolve discrepancies in clinical data with clinical sites.
• Other duties as assigned.
• Travel maybe required.
• Clean driving license.
• To represent Wayshine in a professional manner at all times maintaining strict confidentiality with Wayshine’s information. -
Job Description for LCRA/SCRA
Job/position information
Job/position Name
Leading Clinical Research Associate / Senior Clinical Research Associate
Job/position No.
Department
Research and Development Department
Immediate Superior
Project manager
Term of employment
Jul-2024 —— Jul-2027
REQUIRED QUALIFICATIONS AND EXPERIENCE
1) Experience and knowledge
Required
• At least bachelor’s degree in Medical/Nursing or qualification in Nursing/PharmacyBiological Science/
• Minimum of 4-5 years’ monitoring experience
• Knowledge of the Clinical Development whole process; including but not limited to monitoring activities, QC, etc,
• Involvement in protocol, CRF, or other trial-related development activities behaviors
• Familiar with ICH GCP and applicable local regulations
• Proficient knowledge of regional healthcare environment
• Experience in Investigator contract management, if applicable in other countries
• Computer literacy (e.g. EDC, CTMS, MS Office, etc.)
• Excellent verbal and written communication skills in English and other language(s) as appropriate for country
• Highly self-motivated and proactive, with a keen attention to detail
• Goal oriented, able to effectively prioritize and execute tasks in a high-pressure environment
• Effective teamwork and ability to work in a cross-functional team environment
• Excellent written and oral communication skills, including presentations
• Strong interpersonal skills, excellent relationship-building and negotiation skills
• Ability to work independently and strong problem-solving skills
• Excellent organizational and time management skills as well as working flexibility
• Willing and able to travel
2) Preferred
• Experience in project management
• Experience in participating in oncology studies
• Experience in participating in audit CDE’s audit
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Job Description – Clinical Project Manager (CN)职位信息
对所负责的临床研究项目进行全面的管理，督导按时完成临床试验在国内的全面启动、执行及结束工作，并及时与所有CRA及其他部门人员进行沟通和协调。
具体包括：
1. 根据公司新药研发的规划及资源预算在预算内高质量实施管理新药注册临床试验、国际多中心临床试验；
2. 根据医药开发部发展目标，参与制定临床开发部的年度发展计划和资源预算，制定所负责的临床试验项目预算，并根据与第三方签订的合同控制、调节、管理试验费用开支；
3. 对所负责的临床试验项目进行全面的质量控制与管理，确保所有试验严格按照临床试验方案、相关SOP和中国法规进行，督导按时完成临床试验的启动、执行及结束工作，并及时与所有项目成员及其他部门人员进行沟通和协调，定期及时向团队内部成员及利益相关方跟新进展；
4. 与项目成员协作完成临床试验方案、知情同意书，临床研究报告，年度安全报告，研究专用文件、试验主文件 (TMF) 和电子试验主文件 (eTMF)等相关文件；
5. 根据需要进行外部合作方的审查选择，对CRO等外部合作方进行相关培训和管理；
6. 定期与研究者保持沟通，建立良好的合作关系；
7. 和相关部门配合，做好临床试验相关的支持和协助工作；
8. 根据需要承担职责范围内的其他各项工作。
9. 及时发现风险，并与团队成员和其他利益相关者合作制定和实施降低风险的计划，向利益相关方包括CMO及时汇报
10. 管理/监督研究产品和协调流程，负责研究产品放行审核与批准
11. 确定、选择和监控临床研究试验地点的表现；为所有地点互动访问准备准确、及时的访问报告；
12. 执行数据清单和汇总表的临床数据审查，包括查询生成。审查和/或提交研究伦理委员会/监管文件；审查关键研究质量指标。
任职要求：
1. 医学或药学相关专业，本科及以上学历；
2. 具有在制药企业或CRO至少5-6年以上临床研究工作经验，至少3年以上临床项目管理的工作经验；具有非小细胞肺癌及脑癌二，三期临床项目管理经验为优
3. 全面掌握临床试验管理规范的知识；
4. 熟悉药物研发的全过程，对临床研究的各阶段各部门配合工作完全了解；
5. 具备中心培训和研究者会议演讲的技能；
6. 熟练的英语听、说、读、写能力；
7. 熟悉《药品管理法》、《新药审批办法》、GCP；
8. 熟悉新药研发的基本流程和新药申报的要求。
9. 有较强的沟通、表达、项目管理及组织协调能力，有高度进取心。
10. 具有Project Management Professional (PMP)， Certified Clinical Research Professional (CCRP)， Certified Clinical Project Manager (CCPM) 证书优先
