Sr. Clinical Research Manager (职位编号：83887035)社

面议

成都市本科及以上7年及以上

发布时间：2023-09-06

职位描述

工作职责

Directly manages and develops 8-12 Sr. Site managers and Site Managers. Assures hiring, training, development, compensation and advancement are in line with talent and job expectations. Through effective management and development of direct reports, the Manager of Monitoring & Site Management ensures quality and compliance as well as ensuring country’s objectives are met. Provides expertise and strong leadership and management to direct reports and maintains a motivated and competent staff.Ensure projects/studies are resourced appropriately by allocating or hiring the appropriate staff to deliver project/study goals and by critically analyzing project/study needs while also managing and measuring the workload and requirements of direct reports. These activities are done in close alignment with Country Head and peers.Accountable for all operational activities related to global and country procedures applied in the site management of applicable Phase I and Phase II-IV clinical trials. This includes country feasibility, site selection, site initiation, patient enrollment and data cleaning processes direct reports are responsible for. The GSM Associate Clinical Research Manager assures that each direct report delivers high quality study data required to support ethical standards and regulatory submissions in compliance with global operating standards.Responsible for managing internal costs associated with direct reports and participates in the Country Head of Site Management’s preparation and tracking of the overall departmental operating budget. Responsible for tracking insourced costs appropriately and provides estimates and accruals to Country Head on a monthly basis.Quality Oversight - Oversees Corrective Actions / Preventive Actions (CAPAs) of direct reports to ensure timely and sufficient resolution. Conducts Monitoring Oversight Visits for each Site Manager as GSM expectations to ensure Site Managers are trained appropriately and to identify potential training or development needs. Participates in Audit Review Meetings and reviews all responses to audit findings prior to submission. Develops and implements training and development plan in a timely manner based on any deficiencies found or areas for improvement. Continuously and proactively identifies and proposes solutions for process improvement opportunities to Country Head GSM, and communicates best practices to entire monitoring staff. Participates as member of Expert Working Groups and provides feedback on SOP updates.Coordinates responses of audits with Global Quality Management. Proactively identifies actions to be taken at the country level to improve upon audit and inspection findings. Supports Country Head with follow-up of all Regulatory Inspections, Regulatory concerns related to investigator integrity, GCP and the veracity of all clinical data in NDA, CTD, PLA, SNDA and IND submissions.Contributes to delivering Training programs developed by GCDO ICH-GCP Training as well as coordinating all training needs for permanent and insourced Sr. Site managers, and Site managers. Requires thorough understanding of global and local processes, Global Drug Development and associated Global Standard Operating procedures (SOPs). Contributes to development of country clinical investigator network to support the portfolio needs for clinical trials. Collaborates with Medical Science Liaison management to cultivate and enhance clinical investigator relationships to support business strategy
任职要求

Bachelor’s degree (or equivalent) with 6 years’ relevant healthcare experience including 4-6 years’ relevant clinical development or clinical operations experienceIn-depth knowledge of clinical development and drug development process, global clinical development processes, ICH-GCP, applicable legal, compliance and regulatory requirementsLeadership, motivational, and collaborative skills are critical. Ability to lead staff in changing times as well as strong interpersonal skills in the management and development of people in a global environment Administrative, financial, and technical skills are required, as well as effective verbal and written English communication skills in relation to both internal and external colleaguesAble to work effectively within a multi-cultural, global, matrix organization

其他要求

招聘人数：1人
职能类别：临床研究经理CRM

公司介绍

拜耳是一家全球化创新型企业，在生命科学领域的健康与营养方面具有核心竞争力。拜耳致力于以创新的产品帮助解决当今人类社会所面临的一些重大挑战。随着人类预期寿命不断延长，人口不断增长，拜耳通过专注于预防、缓解和治疗疾病的研发活动来改善人们的生活质量。与此同时，拜耳通过突破性创新引领农业未来，帮助农户、消费者得到健康、安全、可负担的食物，并且生产过程对社区、对环境友好。“拜耳：科技创造美好生活”是我们的使命，我们的目标是改善人们的生活质量。

拜耳于1863年创立，迄今已有150多年的历史，公司总部位于德国勒沃库森，全球拥有超过11万名员工。2018年财富世界500强排行榜中拜耳排名193位。早在1882年拜耳公司首次进入中国市场，至今已经超过130年。随着中国成为世界上增长最快的市场之一，拜耳也逐步加大了在这里的投入。拜耳中国总部位于上海，截至2018年12月底，拥有超过9,000名员工。2018年拜耳中国的销售额达到31.27亿欧元，折合人民币超过235亿元。

拜耳在中国有三大事业部：处方药、健康消费品和作物科学，并运营着多家工厂。早在1936年拜耳就开始在上海生产阿司匹林，目前本地生产在中国的销售额中所占比重越来越大。伴随着正在进行的一些重大投资项目，拜耳致力于成为在中国发展的主要引擎。

多年以来，拜耳作为人们心目中的理想雇主屡获殊荣，2018年我们荣膺中国杰出雇主、中国典范雇主、非凡雇主101-年度多元雇主、中国大学生喜爱雇主、最受***欢迎雇主等多个奖项。同时，拜耳也是提供均等机会的雇主。我们尊重并公平对待他人，不论其**、国籍、民族、文化、性别或性取向，我们重视并弘扬多元文化。“敢想|勇为”（Passion to innovate | Power to change）是拜耳的雇主品牌宣言，它概括了拜耳作为雇主的全部特点：其工作文化与公司对目前和未来员工的期望以及对他们的回报。

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