London, Greater London, United Kingdom
Job type: fulltime
Job industry: Administration
Responsible for analyzing contract requests/needs from operating companies and translating into appropriate contracts/budgets for company sponsored and investigator initiated clinical trial agreements and other relevant legal documents as they relate to various clinical projects.
Provide specialized support for negotiations in confidentiality agreements, informed consent forms and other ancillary contract documents as required
Analyze investigator grants for fair market value aligned with regional knowledge and the grant pricing guidelines, and based on adequate scope of work, clinical trial protocol and other clinical trial information. Participate in and/or lead the approval escalation of grants as appropriate.
Provide guidance to CROs contracted to negotiate CTAs globally, inclusive of training and supervision.
Determine potential needs for contract amendments and manage amendment life cycle.
Ensure that contractual terms and provisions are in compliance with corporate process, systems, and strategies.
Work with the global C&G team as necessary to review and analyze contractual terms and conditions in order to reach acceptable language. * Assess risks of budget and legal provisions in conjunction with members of the C&G team and support functions and communicate such to stakeholders.
Liaise with C&G management, Healthcare Compliance, Risk Management, Privacy and other stakeholders to obtain guidance and escalate issues as appropriate.
Assume responsibility for all aspects of legal document and metrics tracking.
Review, authorize and/or manage payments. Assist clinical operations or clinical team in ensuring that investigator grants comply with overall study costs and compliance guidelines.
Mentor and train new contract coordinators and analysts
Bachelors degree in appropriate scientific or business discipline
Strong background experience and/or equivalent competencies in pharmaceutical industry/clinical research
Must have a working knowledge of the clinical development process with 2 years of UK Site negotiation and contract experience
Excellent communication skills (both oral and written)
Familiarity with healthcare compliance and other relevant guidance (HIPAA, FCPA, Safe Harbor, etc.) a plus
Working knowledge of PCs (MS Office suite at a minimum) and database management
Fluency in English is required
Previous experience working in virtual teams preferred
Please note you MUST have experience working within clinical research from Pharma or CRO and you MUST have the right to work in UK without the need of sponsorship.