临床总监

面议

市辖区

刷新时间：2022-06-02

职位描述

  AD， SM级别的clinical ops, 最好做个biotech start-up  

医学首席执行官/总监：
根据市场调研，提出未来五年至十年的临床试验战略方针、制定临床项目内容以及实施进度。基于目前已完成的临床试验，组织相关的科学信息，优化数据分析，健全并合成科学论述。 作为医学专家参与投资人和合作伙伴的专业沟通，并参加医学大会的学术交流。把公司创新的再生医学技术提升到一个崭新的高度。

老总今天说不用太资深，有好的学位背景就行。年薪40-70万，这样的级别。

  Sr. Clinical Manager/Director
The Sr. Clinical Manager/Director is responsible for assisting in the strategic planning, oversight and execution of all clinical trials across programs. The incumbent may also directly manage studies. Responsibilities include creating timelines and budgets, overseeing day-to-day operations, ensuring studies are conducted in accordance with regulatory requirements and within established timelines and budgets. Additionally, the incumbent will be responsible for leading cross-functional teams and managing relationships with investigator sites, vendors and consultants.
The CRA Manager/Sr Manager is accountable for operational planning and execution at the study level with responsibility for clinical study plan and execution (from planning start-up, conduct, reporting and close out) including timeline, quality and budget. A key focus will be the oversight of and interactions with CROs and other 3rd party vendors to ensure study milestones and deliverables are achieved according to agreed quality standards and timelines and that quality of data is suitable for regulatory submission.
Essential Functions
1.Lead/participate in program strategy meetings and contribute to the operational strategy of responsible program/studies.
2.Responsible for the selection and oversight of external service providers, including CROs and other vendors as necessary.
3.Develops and manages clinical trial budgets, providing ongoing financial reporting
4.Leads/participates in vendor/site budget negotiations and assists with Clinical Trial Agreements as necessary
5.Manages responsible study(ies) within agreed timelines and budget and in accordance with internal SOP's and GCPs
6.Coordinates cross functional efforts to achieve study objectives and goals.
7.Identifies and communicates study issues that will impact budget, resources and timelines.
8.Establishes and maintains relationships with assigned investigator sites, vendors and consultants.
9.Participates in the preparation, review and finalization of clinical study-related documents such as protocols, protocol amendments, Clinical Study Reports (CSRs), regulatory submissions, and other publications as required.
10.Ensures documentation prepared internally or by CRO(s) is completed in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies/programs.
11.Participates in the ongoing and final review of clinical study data to ensure the data is accurate and complete, and assessment of the impact of this data to the study and program.
12.Ensures Trial Master File is accurate and up to date
Job Requirements
1.6years clinical research experience in an industry setting and a minimum of 5 years project-lead or management experience
2.Previous experience managing clinical operations staff across multiple programs
3.Bachelor's and/or master's degree in a scientific discipline, MD, RN, BSN, degree or equivalent
4.Interpersonal Skills - Must have strong leadership abilities and the communication and interpersonal skills needed to influence decision-making in a diplomatic manner. Demonstrated effective team leadership in cross-functional matrix teams.
5.Communication Skills - Excellent oral and written communications with ability to present data to all levels of audiences.
6.Productivity/Organizing/Planning - Meets deadlines, demonstrates effective use of time, and handles multiple assignments simultaneously. Ability to proactively identify and take appropriate initiatives to fulfil the requirements of the role. Ability to maintain a high level of productivity with minimal supervision.
7.Strategic Thinking - Strong capability of strategic thinking and proposing innovative solutions to issues.
8.Collaboration & Teamwork - Advanced competence in collaboration & teamwork, communications, influence, conflict resolution, strategic agility, planning & organizing, team building, driving results and problem solving.
9.Experience in writing clinical study protocols, informed consent forms, and other clinical documents
10.Solid understanding of NMPA and other regulatory requirements that may impact global clinical studies
11.Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial management
12.Willing and capable to manage multiple projects, negotiate budgets, timelines and responsibilities
13.Working knowledge of MS Project for develop  

其他要求

招聘人数：1人
职能类别：临床总监

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业，总部位于杭州，下属有上海、南京、广州、武汉等多家分公司，同时自主开发国内领先的猎头办公系统及医药人才网站，全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台，在欧、美、日等国家建立了海归引进平台，同时积极开展医药高等院校公益系列讲座，搭建了以人力、企业为主体的立体化咨询服务网，为医药企业人才队伍建设发挥了积极重要作用，为很多医药企业解决了高端人力之困。