高级临床项目经理岗位职责

工作职责:
1.负责制定临床项目计划书以及把控项目整体进度，确保临床研究过程符合GCP及研究方案；
2.负责与研究中心的沟通协调，审查并修订相关文件报告，组织协调项目稽查与官方视察等；
3.负责与申办方进行沟通和协调，并按项目要求提供定期/不定期的报告；
4. 按照制定的试验方案，完成相应的病例报告表、原始病历本和项目管理表格等文件资料；
5.与项目相关的其他人员进行有效的沟通与协调，如医学写作，数据与统计等；
6.全面负责本项目组成员的带教培训及日常管理工作，包括项目启动前的培训、协助CRA制定监查计划、审阅项目组成员的所有报告等。
任职资格:
1、本科及以上学历，临床医学、药学、护理或生命科学相关专业；
2、基本的ICH GCP及相关法规知识；英语读写能力熟练，能独立查阅文献；
3、能熟练使用常见办公系统，例如Excel, Word, PowerPoint, Outlook等；
4、8年及以上临床试验相关经验，至少2年项目管理经验，具有抗感染、疫苗、肿瘤项目经验者优先；能够适应一定频率的出差；
5、目标导向，责任心强，具备良好的沟通协调能力，解决问题和自我管理能力；能够独立、高效、主动地发现和解决问题；能同时完成多任务的处理，能关注细节并按优先级处理好各项事宜；具备良好的领导力，以及团队合作精神。

岗位职责
1、进行项目的临床阶段立项、计划、预算、文件准备、团队搭建、CRO招投标、研究中心筛选、伦理递交及获批日常培训，研究者会议，数据审核会议，尽职调查。
2、启动中心入组，做好CRO的监管、研究者沟通、入组进度督促、跟进数据质量管理、风险预警沟通。
3、做好数据清理，按计划完成CSR各项支持工作，关闭中心，及配合临床核查工作。
任职资格：
1、全日制本科或硕士学历，医药相关专业
2、经验要求：8年以上相关工作经验，同岗位3年以上
3、执业资格/职称：执业医师或药师优先考虑
4、业务技能：较强的人际沟通能力和谈判能力；有外资、大药厂及大CRO公司经验者优先考虑。

DUTIES & RESPONSIBILITES
1. Forecast timelines, budget & FTE resource
2. Take a key leadership role in the management of studies’ timeline, quality, cost.
3. Ensures all activities (including HGR activities)must be in compliance with SOPs, applicable policies, related standards, in line withGxP, local laws regulations.
4. Monthly track manage the agreed studies’timelines, budget, resource, highlight significant variance take appropriate actions to get studies on track.
5. study information VCV, Evidence Connect system, Medical Tracking system, to global & regional team to ensure up-todate information captured.
6.Review approve project relevant documents.
7.Lead preparation delivery of study documents (e.g.Protocols/amendments, ICF,CRF, studies’ related plans forms, etc.)
8. Prepare lead investigatmonitor
meeting.
9. Ensure AEs/SAE reporting according to GCP regulation.
10. Plan lead activities associated with study level Quality Control plan.
11. Develop & manage contingency risk plans to assure timely delivery to quality, budget, time escalate issues to stakeholders as
appropriate.
Job requirements
1.10 years’ experience in clinical research studies/programs in a pharmaceutical company CRO setting.
2. About 5 years of global project management experience.
3. Clinical research experience in multinational pharmaceutical company.
4. Experience of collaborating with global team cross functional team.
5. Bachelhigher degree in Science, Medical Pharmaceutical Background
6. Leadership Skills as the leader role of project team. Strong interpersonal skills, with the ability to work effectively with others at all levels of theganization. Good communication: be able to
convey information clearly accurately. Strong interpersonal skills with the ability to work effectively with others at all levels of theganization
7. Learning agility: swiftly acquire new knowledge skills apply effectively in practical works.
8. Presentation skills: confidently fluently delivering project introductions, progress reports,outcome demonstrations. Proven ability to deliver training
9. Build relationship: Creates good impressions with people proactively builds a network of key contacts (internal external). Knows who is important has good relationship with those people. Builds trust quickly, listen to other’s points can talk easily to people from a wide range of backgrounds. Inspires team through impactful compelling communications.