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● Services rendered will adhere to applicable client's 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 first line negotiators and others as required.
● Provide specialized support and guidance on the negotiation of CTAs and CDAs
to first 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 communicate
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.
● Participate in 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 (subject to and within the
limits of the client's negotiation parameters and the client's form of written
contract). For the avoidance of doubt, the service shall not have authority to
sign contracts on behalf of the client's party.
● 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.
● Collaborate with internal stakeholders to ensure proper dissemination and
management of knowledge.
● Monitor departmental processes to ensure compliance with corporate policies.