Ref #: 24912

Employment type: Permanent - Full-Time

Location: Hungary

Posted: 29-Oct-2020

Description

Description:

* 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 J&J 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

Profile:

•* Bachelor’s degree in appropriate scientific or business discipline
•* 3- 5 years’ experience and/or equivalent competencies in pharmaceutical industry/clinical research
•* Must have a working knowledge of the clinical development process with 2 years of 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