Clinical Operation Lead

面议

上海市

刷新时间：2020-12-02

职位描述

Job Description
We are looking for a senior staff of clinical operations to join our clinical development team. This clinical operation lead is a key role in planning, initiation, execution and closure of planned clinical trials through outsourcing strategy. This role is responsible for operational management of clinical studies, ensuring the compliance with timelines, milestones and budget and works closely with CROs/vendors，internal medical lead and regulatory lead to drive the clinical trials forward. Activities include but are not limited to: vender selection and vender management, site selection, maintenance of close contact with PIs, oversight of CROs/venders’ performance to ensure
Key Responsibilities:
· Serve as the primary point of contact of clinical trial for Sponsor.
· Management of all logistical and operational activities from study start-up through closeout, ensuring adherence to regulatory guidelines, company SOPs, study timelines and inspection readiness.
· Oversight and management of CRO and third-party vendors.
· Review/develop, communicate and evaluate trial management plans to include trial team
objectives, workflows and timelines.
· Development of recruitment strategies to increase patient enrollment. Overseeing site initiation, interim monitoring and close-out visits as needed to include training materials used during visits.
· Responsible for the financial management of the clinical trial including budget planning and tracking, resource allocation and preparation of quarterly reports.
· Providing support and assistance to sites for audit and inspection readiness. Requirements:
· University degree in biological/pharmaceutical science or medicine. Advance degree is preferred.
· 3-5 years’ experience in pharmaceutical industry in clinical operations
· Must have a thorough knowledge of clinical research concepts, practices, and ICH Guidelines
regarding drug development phases, clinical research and data management methods.
· Good interpersonal communication skills.
Self-motivated, willing to learn, organized, and able to work independently and effectively.

其他要求

招聘人数：1人
职能类别：临床项目经理PM

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。