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Contracts Specialist

Location: High Wycombe, Buckinghamshire Salary: £30.00 - £39.00 per hour
Sector: Pharmaceuticals Specialism:
Type: Contract Contact: Matt Henocq

Contracts Specialist

Home based or office based from High Wycombe

Position Summary

Support in the creation and maintenance of Clinical Trial Agreements, Confidentiality Agreements and negotiation guidelines. Support 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 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 complex legal issues while ensuring compliance with company process and strategy and subsequently disseminating information to negotiators.

Tasks/Duties/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 required
  • Provide specialized support and guidance on the negotiation of CTAs and CDAs to first line negotiator
  • Work with the legal department to create 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 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
  • Collaborate with internal stakeholders to ensure proper dissemination and management of knowledge
  • Monitor departmental processes to ensure compliance with corporate policies

Required Knowledge, Skills and Abilities

  • At least 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
  • Must have a working knowledge of the clinical development process
  • Fluency in English is required
  • 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
  • Must demonstrate strong interpersonal and leadership skills with a strong drive to mentor and coach team members

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. Privacy Policy. Equal Opportunity and Diversity Policy.

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