Ref #: 26344

Employment type: Permanent - Full-Time

Location: China-Beijig/Shanghai

Description

Description:

* Act as liaison between Law Department, regional/country clinical operations personnel, HCC and CGAs/CGA Management during issue escalation.
* Assist in coaching/mentoring staff members.
* Analyze the issue and manage the process in order to expedite resolution of complex legal issues in clinical trial contracting process.
* Track inquiries and monitor trends to identify need for additional standardized guidance and work with stakeholders to prepare such guidance for review/approval.
* Serve as facilitator for healthcare compliance policies in clinical trial contracting.
* Contribute in the capacity of subject matter expert to applicable intra-departmental functions to ensure consistency and compliance with process, external communications and policies (clinical trial agreements, confidential disclosure agreements, informed consent forms, etc.).
* Liaise with all members of clinical team as needed on complex and high risk issues in addition to representatives of investigator sites, academic research organizations, contract research organization, and site management organizations as directed.
* Lead/conduct contract negotiations on high risk terms and conditions and complex agreements and other relevant legal documents related to clinical trials.
* Responsible for independently coordinating assessments from stakeholders such as clinical team, law department, and internal team where appropriate to evaluate risks of legal terms and conditions and guiding preparation of escalation for business decision.
* Liaise with legal department and internal stakeholders as appropriate to prepare, organize and maintain contract templates in accordance with changes in laws, regulations, or corporate policies.
* Identify and promote best practices through adherence to SOPs, ethics and departmental compliance as determined by GCO management as well as R&D companies, corporate, HCC and QA guidelines.
* Compile, document, and organize regional and country level intelligence related to clinical site contracting.

Profile:

* Juris Doctor (JD) degree or paralegal certification required
* At least 4 years experience with contract law in the pharmaceutical/clinical research industry and/or equivalent competencies in relevant fields with demonstrated ability to conduct legal research and analysis
* Must have a working knowledge of the clinical development process with at least 3 years of contract negotiation experience
* Excellent oral and written communication skills and sensitivity to cross-cultural communication
* Strong relationship management skills and experience
* Ability to work effectively across all levels of management
* Strong and proven issue identification and problem resolution skills
* Sense of urgency with ability to manage competing priorities while meeting deadlines
* Must demonstrate innovative spirit, strong interpersonal and leadership skills with a strong drive to mentor and coach team members.
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