Services Overview:
Provide services in the creation and maintenance of Clinical Trial Agreements, Confidentiality Agreements
and negotiation guidelines, services in the development of training related to Clinical Trial Agreements,
Confidentiality Agreements and negotiation guidelines as required. Lead/support on the review and
negotiation of customized and complex templates. Expedite contract negotiation and execution by acting
as resource for *** line negotiators to streamline requests to law department and avoid duplication of
efforts among negotiators. Coordinate with legal department to resolve complex legal issues while
ensuring compliance with company process and strategy and subsequently disseminating information to
negotiators.
Deliverables:
- Services rendered will adhere to applicable SOPs, WIs, policies, local regulatory
requirements, etc.
- 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 *** line
negotiators and others as required.
- Provide specialized support and guidance on the negotiation of CTAs and CDAs to *** line
negotiators.
- Work with the legal department to create risk assessments to support the decision-making process.
- Assess risks of legal terms and conditions independently and communicating them to stakeholders
such as clinical team, law department, and internal team where appropriate. Provide guidance 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 complex 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 directed.
- Identify and promote best practices. Adhere to SOPs, ethics and departmental compliance as
determined by GCDO management as well as R&D companies, corporate, HCC and QA guidelines.

Education and Experience Requirements:
- Juris Doctor (JD) degree, Master of Laws (LLM) degree, paralegal degree, or local equivalent.
- 5 years’ experience with contract law in the pharmaceutical/clinical research industry and/or
equivalent competencies in relevant fields with demonstrated ability to conduct contract
negotiation, legal research and analysis.
- Working knowledge of the clinical development process.
- Fluency in English.
- Excellent oral and written communication skills and sensitivity to cross-cultural communication.
- Strong relationship management skills and experience.
- Strong ability to work across different geographic regions.
- 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.
- Working knowledge of PCs, MS Office, and database management.
- Business acumen and complex project management skills.
- Demonstrate strong interpersonal and leadership skills with a strong drive to mentor and coach
team members.