北京招聘

Overall Job Purpose:

The Project Manager (PM) acts as a key liaison person between Choice Pharma and the client for specific projects being performed by Choice Pharma. The PM is responsible for all management and coordination of project activities to assure projects are conducted on time and budget, with good compliance with ICH-GCP and Choice Pharma/Client’s SOPs. The PM should be able to make effective decisions independently with in-depth business understating and study experiences to ensure the profitability of a project and meet or exceed client’s expectation.

1. Key Accountabilities
1.1 Project Management
· Lead and manage the project team to conduct assigned local/regional/global studies with activities including but not limited to:
Ø Planning clinical resource for assigned project with (Associate) Clinical Research Manager (CRM)/ (Associate) Clinical Research Director (CRD).
Ø Drafting Monitoring Plan, setting up targets and assigning tasks for project team members. Motivating team to work together in the most efficient manner.
Ø Supporting local investigator meetings; ensure the Contracts and other applicable regulatory documents are obtained prior to study start.
Ø Preparing and ensuring all study documents and tools are in place prior to study start.
Ø Leading the team kick-off meeting and study-specific training, ensuring the scope of the study is well understood by all team members.
Ø Initiating and coordinating site selection activities.
Ø Coordinating and supporting regulatory applications at the country level and facilitating the IRB/IEC submission at the site level where required, including drafting of Informed Consent Document, advertising material, etc.
Ø Reviewing CRA’s reports and instructing them to resolve or escalate issues identified at sites in a timely manner.
Ø Conducting accompanied monitoring visits to CRAs to ensure study quality and milestone achievement where needed.
Ø Conducting quality management for assigned projects strictly in compliance with ICH-GCP, applicabel SOPs.
Ø Tracking and ensuring clinical projects are effectively executed and completed within the budget and timelines. Conducting pro-active project management to identify potential challenges and to develop effective mitigation plans and to appropriately escalate and inform all relevant parties.
Ø Overseeing the Investigational Product (IP) and other study materials supplies to ensure always sufficient for the study.
Ø Leading regular meetings with the Client to report the project progress.
Ø Leading team meetings regularly to ensure all team members are aware of the scope of work, timelines, updated information and any changes in the study.
Ø Collaborating with the CRAs to ensure all sites be closed out appropriately per applicable SOPs and other related requirements.
· Act as the key liaison person with specific study Sponsor.
· Participate in the training and coaching new associates.
· Provide (A)CRM/ (A)CRD with team members’ performance as needed for periodic performance review.

1.2 Relationship Management
· Contribute in building strong teamwork spirit.
· Establish and maintain effective working relationships among the whole study team.
· Support the development and maintenance of relationships with external personnel, including but not limited to:
Ø Personnel from client companies / potential client companies.
Ø Investigators and site staff.
Ø Relevant healthcare professionals.

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.
· Critical thinking and problem solving skills.
· Strategic-thinking and dcision-making skill.
· Effective time management in order to meet daily metrics or team objectives.
· Good people management skills.
· Excellent cnflict management skills.
· Client focused approach to work.
· Ability to manage multiple and varied tasks.
· Ability to travel as needed.

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 in local language and English.

2.4 Minimum Work Experience
· At least 3-4 years of medical science background or relevant experiences in clinical research in pharmaceutical companies or CRO.
· Proven excellent site management capabilities with demonstrated capability of problem solving.
· Experienced in clinical project management and people management.

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