长沙招聘

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.