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Job Function:

R&D Operations

Job Sub Function:

Clinical Trial Project Management

Job Category:

Professional

All Job Posting Locations:

Shanghai, China

Job Description:

Position Summary:

Support in the creation and maintenance of Clinical Trial related agreements and negotiation guidelines. Support in the development of training related to Clinical Trial related agreements and negotiation guidelines as required.

Lead/support on the review and negotiation of customized and sophisticated templates. Expedite contract negotiation and execution by acting as resource for first line negotiators to streamline requests to law department and avoid duplication of efforts among negotiators.

Act as a point of contact with legal department to resolve sophisticated legal issues while ensuring compliance with company process and strategy and subsequently disseminating information to negotiators.

Principal Responsibilities:

• Support creation and maintenance of contract templates in accordance with changes in laws, regulations, or corporate policies

• Support creation and maintenance of fallback language and negotiation guidelines related to contract templates

• Support training on contract templates and fallback language and provide training to first line negotiators and others as the need arises

• Provide specialized support and mentorship on the negotiation of CTAs and CDAs to first line negotiators

• Work with the legal department to build risk assessments to support the decision-making process

• Access risks of legal terms and conditions independently and communicating them to stakeholders such as clinical team, law department, and internal team where appropriate. Provide mentorship to 1st line negotiators, stakeholders and others as required

• Lead negotiations on Master Agreements and custom templates or those requiring extensive modifications and identify potential risks to the business

• Lead contract negotiations on terms and conditions of high-risk and sophisticated agreements and other relevant legal documents as they relate to clinical trials and company/departmental policies

• Coordinate with cross-functional departments to ensure consistency and compliance with process, external communications and policies

• Assist in coaching/mentoring staff members

• Liaise with all members of clinical team as needed in addition to representatives of investigator sites, academic research organizations, contract research organization, and site management organizations as advised

• Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as determined by GD management as well as R&D companies, corporate, HCC and QA guidelines

• Collaborate with internal stakeholders to ensure proper dissemination and management of knowledge

• Monitor departmental processes to ensure compliance with corporate policies

• Outstanding customer focus with vision to drive solutions

This is not an extensive, comprehensive listing of job functions and tasks. Other duties may be performed as assigned.

Principal Relationships:

This position reports to Manager of Regional Contract Manager.

Internal:

• Internal Business Partners (CCS, DUs, MADU, HCC, Risk Management, Legal, etc.)

External:

• Medical Centers, Hospitals, Physicians.

• Commercial Suppliers.

• Clinical Research Organizations.

• Law Firms / Outside Counsel.

• Industry associations.

Education and Experience Requirements:

• Law school: bachelor's degree or Equivalent in appropriate scientific or business fields (Preferred MBA or Equivalent Other Juris Doctor (JD), Master of Laws (LLM), or local equivalent).

• At least 5 years' experience with contract law in the pharmaceutical/clinical research industry and/or equivalent proficiencies in relevant fields with demonstrated ability to conduct contract negotiation, legal research and analysis

• Must have a solid understanding of the clinical development process

• 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 handle competing priorities while meeting deadlines

• Solid understanding of PCs, MS Office and database management

• Business acumen and sophisticated project management skills

• Must demonstrate strong interpersonal and leadership skills with a strong aim to mentor and coach team members.

Decision-making and problem-solving

• Adhere to SOPs, ethics and departmental compliance as determined by JRP management as well as business partners, operating companies, corporate, HCC and QA guidelines. Ensure familiarity with departmental and corporate processes including but not limited to the relevant processes associated with GD and operating companies. Comply with requests from QA and auditors.

• Onboard and train new staff and meet regularly with team members to ensure studies are properly supported and identify contracting issues and potential solutions. Assist in resolution of site/study related concerns. Mentor and guide teams on processes and procedures. Serve as a key liaison with management on staff performance and development. Facilitate clear and consistent communications between management and other team members. Identify and implement process improvements. Drive accountability and results.

• Able to work independently as well as in a collaborative team environment.

Other:

• Language Requirement: Fluency in English (business proficiency)

• Travel Percentage: <5% (Domestic & International)

Required Skills:

Preferred Skills:

Analytical Reasoning, Clinical Research and Regulations, Clinical Trial Designs, Clinical Trial Management Systems (CTMS), Clinical Trials, Communication, Data Savvy, Laboratory Operations, Organizing, Problem Solving, Productivity Planning, Professional Ethics, Project Integration Management, Quality Assurance (QA), Regulatory Compliance, Research and Development, Research Ethics, Standard Operating Procedure (SOP)