北京 [切换城市] 北京招聘北京生物/制药/医疗器械招聘北京临床研究员招聘

(Associate) Clinical Research manager

丘以思(上海)医药信息咨询有限公司

  • 公司规模:50-150人
  • 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:2013-01-09
  • 工作地点:北京
  • 招聘人数:1
  • 工作经验:三年以上
  • 学历要求:本科
  • 语言要求:普通话精通
    英语良好
  • 职位类别:临床研究员  临床协调员

职位描述

Overall Job Purpose:
The (Associate) Clinical Research Manager (CRM) is responsible for all activities related to the project planning, conducting and completion within their assigned territory. The (A)CRM is responsible for hiring, training and assigning CRAs and CTAs, managing their performance, ensuring their compliance with ICH-GCP and local regulations.

1. Key Accountabilities
1.1 Line Management
? Identify, hire and supervise CRAs and CTAs and allocate tasks to them.
? Provide effective line management, motivation, coaching and training to CRAs and
CTAs to improve and maintain their individual performance.
? Establish a strong culture of open communication, honesty, and create an
environment of transparency, with time for reflection and continuous improvement.
? Implement an effective training programme to train new CRAs and CTAs on SOPs and
relevant government regulations.
? Set annual objectives for all CRAs and CTAs with supporting short-term and
mid/long term personalized development plans.
? At least annually assess the performance of CRAs and CTAs.
? Ensure all CRAs and CTAs are kept informed of territory performance and
SOPs/policies changes.
? Ensure a positive "customer service" focus at all times.
? Manage and direct CRAs with problem solving at the site level where needed.

1.2 Project Management
? Ensure efficient implementation and maintenance of SOPs and Policies in
compliance with ICH-GCP, Local Regulations and other applicable laws and
guidelines.
? Support in the development and maintenance of project plans, budgets, schedules,
milestones and timelines.
? Establish and maintain project tracking and management tool.
? Proactively identify issues and keep both client and internal projects on track
and on budget.

1.3 Relationship Management
? Be responsible for creating and maintaining a strong and harmonious CRA and CTA
team spirit to ensure successful delivery of key business objectives /
initiatives.
? Establish and maintain effective working relationships with the other departments
as appropriate.
? Support in the identification and building of new relationships, and further
development of existing relationships with external personnel, including but not
limited to:
Ø Personnel from client companies / potential client companies.
Ø Investigators and site staff.
Ø Other institutional staff.
Ø Relevant healthcare professionals.
? Support in the development of working relationships with regulatory authority
and IRB/IEC personnel within the constraints of any local guidelines and
regulations.

1.4 Business Development
? Input into the local and regional business development strategy and will be
responsible for the maintenance of their local component of a global business
development database.

2. Job Requirements
2.1 Skills
? Excellent interpersonal, verbal and written communication skills.
? Very good working knowledge of relevant software such as MS-office (Excel, Word
and PowerPoint, etc).
? Strong organizational skills with attention to details.
? Strong leadership skills.
? Excellent organizational and problem solving skills.
? Strategic-thinking and decision-making skill.
? Effective time management skills and ability to manage competing priorities.
? Strong people management skills.
? Strong conflict management skills.
? Ability to manage multiple and varied tasks.
? Client focused approach to work.
? Able to travel when required.

2.2 Education
? Bachelor degree or above in medical, nursing, pharmaceutical or other bio-
science related area.

2.3 Language Skills
? Proficient written and oral skills both in local language and English.

2.4 Minimum Work Experience
? At least 5 years of clinical research experience with at least 2 years of
experience in a leadership capacity in pharmaceutical companies or CRO.
? Proven excellent site management experience with demonstrated capability to
solve problems and mediate complex compliance issues.
? Experienced in clinical trial management and people management.
? Expert knowledge of ICH-GCP and local regulatory requirements.

公司介绍

Clinipace Clinical Research,一个基于科技的全球性全方位服务的数字化合同研究组织(dCRO)。我们开创性的开发了依靠技术创新的CRO服务模式,以满足风险投资支持的,中型的战略性制药,生物技术公司以及医疗器械公司的研发需求。

借助于我们专有的TEMPO?电子化临床试验平台,我们的专家团队用他们丰富的治疗领域知识和见解来帮助生命科学公司制定和执行注册策略,临床开发和上市后研究,以确保药物和医疗器械开发计划的成功。

Clinipace的***目标就是通过开拓创新的技术继续坚定不移地致力于客户的成功,以最具性价比的全球性解决方案服务客户,提供高透明度,灵活和高质量的服务。

我们已经开展了超过1500个全球性的临床研究,完成了超过300个注册和开发策略制定项目。治疗领域涵盖如心血管和代谢,中枢神经系统,皮肤,消化,免疫,感染,***,肿瘤,呼吸,风湿和疫苗(和其他细胞和组织疗法)。

Clinipace刚刚庆祝了他们的10周年。如今,Clinipace其总部设在美国北卡罗莱纳州的Research Triangle Park,为横跨4大洲的27个国家提供服务。

因为对更高的数据准确度,经济高效的解决方案和更低的研发成本的需求在不断的增加,Clinipace还在持续的在全球扩张。

最后, Clinipace以正直透明、追求卓越绩效的企业文化邀请您的加入.

公司主页:*************************

最后, 丘以思以正直透明、追求卓越绩效的企业文化邀请您的加入.
应聘邮箱:kding@clinipace.com

联系方式

  • Email:kding@clinipace.com
  • 公司地址:地址:span广州