临床研究医生（CRP）的前景、职责、晋升及薪资！

Clinical Research Physician（简称CRP），临床研究医生，上市前医学CRP以试验方案/研究者手册为核心，是为了完成临床试验的有效/安全性证实，并完成IND/NDA顺利递交。

CRP发展前景

发展前景非常好，可以说是clinical development部门中发展最好（薪资最高）的岗位之一！因为：①CRP门槛高，学历和医生经历硬性要求导致供小于求；②2010年以后外企医学部才陆续把上市前从上市后脱离出来，2017年中国才正式加入ICH，加上整个临床试验环境在中国非常友好，因此未来10年内整体市场对CRP的需求是高速增长的；③受带量采购影响，越来越多的上市后医学转做上市前；④医院把医生当畜生，越来越紧张的医患关系，内卷严重等导致越来越多的医生想要转行，CRP既能满足部分医生的学术情怀又相对轻松！

CRP晋升路线

外资体系:clinical scientist-CRP-Sr CRP-Principle-AD-D-Sr D-Executive D-VP(TAH)-SVP（clinical development head）-CMO（R&D head）

内资体系：医学专员-经理-资深经理-副总监-总监-高级总监-执行总监-副总裁-资深总裁-首席医学官。

CRP主要职责

不同level的主要responsibility不同

Junior level的Responsibilities一般有（节选某司的招聘）:

• Support medical director in drafting clinical trial protocol and study report.
• Contribute to the medical/scientific input given for the development of trial-related documents such as IB, ICF etc. and processes which reside in other line functions.
• Establish and maintain liaisons with investigators.
• Serve as back-up medical monitor to provide medical support to trial sites and clinical operation team.
• Support regulatory filing where medical expertise is required.
• Support drug discovery when clinical experience is needed for the medical “translation”.
• Lead clinical trial data review and generate clinical queries, quality control and data validation for clinical study reports, publications and internal/external presentations.
• Prepare and conduct regular meetings with investigators.
• Support clinical study site and CRO selection in trial conduct and clinical trial outsourcing process.
• Support the regional clinical strategy for a project through Clinical development, in partnership with relevant matrix team members.
• Compliance with GCP, SOP and regulatory requirements.
• Study planning, preparation, conduct and report in terms of timeline, quality and quantity

Senior level的Responsibilities一般有（节选某司的招聘）:

• Drive the development of Clinical Development Plan (CDP) and relevant study designs through team effort; ensure input from internal or external expertise is integrated and reflected in the CDP. Such expertise may include but not limited to key opinion leaders, global Patient Value Unit, regulatory affairs experts, project/study physicians, project management, biostatisticians, and pharmacologists.
• Be responsible for overall implementation of the CDP to ensure timelines, budget as well as deliverables are within expectation.
• Co-author and/or review protocol concept / protocol, other study-related clinical documents according to the CDP, and scientific publications.
• Ensure that medical science is well incorporated into the clinical development strategy, plans and study designs.
• Guide the team through data analyses and review to conclude for study result interpretation.
• Serve as the leader in logic construction in clinical for various submissions across the region, such as CTD/eCTDs, CTAs/CTNs and NDAs or IDLs.

基本senior的CRP就要lead整个临床试验方案的思路和方向，参与重要的试验策略制定等，与PI沟通项目，寻找合适的有影响力的PI等。

当项目进行到不同节点，CRP的responsibility也不同

• 临床试验立项阶段和试验筹备阶段需要：准备临床研究方案，为IND和试验筹备提供医学支持，培训研究团队等
• 准备临床研究报告（CSR）的时候需要完成数据清理与数据库锁定

CRP角色定位

CRP一般隶属于R&D即Research and Development 部门的 Development的医学，cross function的小伙伴还有Clinical operation的CRA或者PM，注册RA，PV警戒，biostatistics统计师，SAS programmer编程，有的还会接触到临床药理，转化医学小伙伴。

CRP薪资

目前CRP市场还处于混乱发展的阶段，仅凭一个title就判断薪资高低是非常愚蠢且肤浅的行为！一个CRP的薪资主要是由以下多个方面综合决定。

• 这个CRP本身的学历条件，之前的临床经验，项目经验，成就，具体什么领域
• 面试时的表现，是否让企业认可你的潜力
• 岗位是否着急，竞争是否激烈
• 岗位需要的经验/特质是否满足
• 公司预算是否充足
• 你目前的薪资基数，涨幅一般有个合理的限度（歪个楼，很多人不会计算自己的薪资）
• 内部同事的薪资，HR一般要平衡下
• 运气因素
• 薪资构成，有的是现金多，有的是option或stock多，有的可以合理避税
• 其他因素：比如家里人是PI或者博导是大佬，这种自带资源的