长沙招聘

职位描述：
PURPOSE
Coordinate and support the delivery of all required start-up contracting activities for selected sponsors, studies or multi-protocol programs as determined by either the agreed algorithm or the Sponsor’s requirements, including pre-award activities. Provide Legal advice on contracting language. Provide support to other the Regional Investigator Contract Analysts
RESPONSIBILITIES
The role holder may be required to cover all or some of the responsibilities mentioned below but will focus on selected activities at any one time, depending on business requirements.
? Develop contracting strategies and proposal text to support the proposal development process.
? Develop contract and budget templates and contracting systems, tools, processes, and training materials for selected sponsors, studies or multi-protocol programs according to the Scope of Work and Project Plan, within the agreed project strategy.
? Ensure collaboration, including communication with sponsors, stakeholders and RSU regions and countries, to successfully deliver the agreed project scope in compliance with sponsor requirements and/or the RSU Management Plan.
? Provide specialist legal, operational and financial contracting support to facilitate efficient business development and initiation and maintenance of clinical trials, whilst enabling compliance with regulatory requirements.
? Create and/or review of core scientific, technical and administrative documentation to support business development and enable study initiation and maintenance, as required.
?Assess and review the contracting landscape and contribute to the collection, interpretation, analysis and dissemination of accurate contracting intelligence to support assigned studies and the wider company, as required.
? Ensure overall contracting efficiency and adherence to project timelines and financial goals; report contracting performance metrics and out of scope contracting activities as required.
? Work with Quality Management to ensure appropriate contract management and quality standards.
? Mentor and coach colleagues as required.
? Deliver presentations to clients as required.
? Ensure accurate completion and maintenance of internal systems (with emphasis on CTMS), databases, tracking tools, timelines and project plans.
? May take a lead role in developing long standing relationships with preferred Quintiles customers.
? Provide legal advice to colleagues in the Asia Pacific region on Investigator Site Contractual documents
? Provide legal advice to colleagues on country specific legal requirements in the Asia Pacific region

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
? Good negotiating and communication skills with ability to challenge
? Good interpersonal skills and a strong team player
? Excellent legal, financial and/or technical writing skills
? Thorough understanding of regulated clinical trial environment and knowledge of drug development process
? Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines
? Knowledge of applicable regulatory requirements, SOPs and company’s Corporate Standards
? Proven ability to exercise independent judgment, taking calculated risks when making decisions
? Good Leadership Skills with ability to motivate, coach and mentor
? Good organizational and planning skills
? Good presentation skills
? Strong knowledge of Microsoft Office and e-mail applications
? Good understanding of clinical trial contract management
? Strong legal knowledge
? Ability to work well within a matrix team environment
? Ability to establish and maintain effective working relationships with co-workers, managers and sponsors.
? Fluent in Chinese both written and oral

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor's degree in a related field and 5 years’ relevant experience, including demonstrable experience acting as a local or regional contract expert.
 
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 extended periods of time.
? Occasional travel. 举报 分享

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.