北京招聘

PURPOSE

Manage the delivery of all required regional start-up or global maintenance activities for selected studies including oversight of the scope of work, budget and resources.

 

RESPONSIBILITIES

Oversee the execution of Start Up and/or Maintenance for assigned projects in accordance with the agreed RSU strategy.

Maintain the RSU Management Plan in accordance with the Scope of Work and Project Plan, within the agreed project strategy.

Ensure collaboration across RSU, including communication with countries, to successfully deliver the agreed project scope in compliance with the RSU Management Plan.   

Assist with review of technical and administrative documentation to support business development and enable study initiation and maintenance, as required.  

Support RSU Lead with initial start-up and maintenance phase activities as an integral member of the study management team.

Determine regulatory strategy/expectations and parameters for submissions and all necessary authorizations; support execution of the RSU plan.

Assist with collection and dissemination of accurate regulatory intelligence to support assigned studies and wider company, as required.  

Ensure overall project efficiency and adherence to project timelines; report performance metrics as required.  

Ensure appropriate quality standards (following RSU Management Plan and relevant Work Instructions) for the duration Start Up (or Maintenance, as applicable).

Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans with project specific information.

Assist in developing long standing relationships with preferred Quintiles customers.

Assist with presentations/training to clients, colleagues and professional bodies, as required.

 

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

Good communication skills (written and oral) 

Good interpersonal skills, a strong team player 

Understanding of regulated clinical trial environment and knowledge of drug development process

Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines

Good leadership skills, with ability to motivate

Good organizational and planning skills

Understanding of study financial management 

Good attention to detail

Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

Bachelor's degree in life sciences or related field, with 1 year’s relevant experience in a scientific or clinical environment or equivalent combination of education, training and experience.

 

PHYSICAL REQUIREMENTS 

Extensive use of keyboard requiring repetitive motion of fingers

Extensive use of telephone and face-to-face communication requiring accurate perception of speech

Regular sitting for extensive periods of time

Occasional travel may be required.

QuintilesIMS pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely. Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials. However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
 
If that is your passion, we have a place for you.