Senior Investigator Site Contract Analyst (Beijing/Shanghai)
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
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.
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.
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