北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京医药技术研发管理人员招聘

CRA Manager/临床研究经理

盈帆达医药咨询(上海)有限公司

  • 公司规模:10000人以上
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2020-12-30
  • 工作地点:上海
  • 招聘人数:若干人
  • 工作经验:3-4年经验
  • 学历要求:本科
  • 职位月薪:2-5万/月
  • 职位类别:临床研究员  医药技术研发管理人员

职位描述

POSITION SUMMARY:
Provides remote and partially face to face management support, trainings and direct supervision to a group of junior Clinical Research Associates in China. Provides training, consultation and oversees quality related for operating activities of assigned staff to ensure project deliverables are met. Participates in CRA I selections and ensure the CRA Is are trained according to the company standards. Identifies resourcing availability and needs to ensure consistent quality of services. Liaise with other departments and support the recruitment activities for the business need.

ESSENTIAL JOB FUNCTIONS:
Act as Manager and Coach for the CRA I during the training program
Work with Program Director and/or other trainers to properly provide training to CRA Is during the 3-4 month program
Makes follow up about the performance and metrics of the trained CRAs after the project work utilization until the CRA I is promoted to CRA II role
Provide daily support to the trainees and timely feedback about the performance and training progression
Conduct 1:1 meetings and group meetings with CRA Is
Evaluate performance on Toll Gates and Sign-off Visits and generally assess Trainee progress and suitability for CRA role
Oversight on Training Visits at an assigned project, arrange and evaluate on Sign-off Visits with qualified assessor
Assist in recruiting new staff as required
Ensure CRA I Training Program timelines and requirements are met
Provide expert operational oversight and guidance to support prioritisation of activities, review and monitor the work performed, and development of contingency plans during the CRA I training program
Ensures quality and adherence to SOP/WI. Ensures all staff follows required training and completes the required documentation.
Updates the training program for the junior CRAs and optimizes the training program according to the China regulations
Ensures staff retention and turnover rates within the expected ranges.

OTHER RESPONSIBILITIES:
Contribute to general process initiatives and take on any other task as assigned.
Moderate travel may be required (up to 25%).

EDUCATION/SKILL/EXPERIENCE REQUIREMENTS:
Requires a B.S/B.Sc./B.A. or equivalent in a biological science field plus progressive experience in clinical development with a minimum of 2 years line management experience. Knowledgeable of Good Clinical Practices (FDA and ICH Guidelines), GCP and other applicable regulations. Effective demonstrated verbal and written communication skills, as well as a strong command of the Chinese language. Good writing and reading skills in English. Ability to work independently and within a team environment is required.. Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail are required.

公司介绍

Why Syneos HealthTM? Join a game-changing global company that is reinventing the way therapies are developed and commercialized. Created through the merger of two industry leading companies - INC Research and inVentiv Health - we bring together more than 21,000 clinical and commercial minds to create better, smarter, faster ways to get biopharmaceutical therapies to patients. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment where you'll be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. Grow your career with a global company committed to shortening the distance from lab to life.

联系方式

  • Email:claire.liu@inventivhealth.com
  • 公司地址:地址:span国贸银泰C座