Investigator Contract Associate

Top 5 pharma company is looking to add an Investigator Contract Lead to their team in NYC, NY.

Position Purpose: Provides contracting support to assigned Development Operations clinical teams (Phase II - IV) and other Contracts & Outsourcing team membersProcesses Letters of Indemnification, clinical study agreements, amendments, etc. for their assigned sitesDirectly negotiates the proposed changes to contract templates within the parameters identified by the Legal DivisionProject Management of assigned studies and contracts between chosen vendors, study teams, finance, legal and others as necessary

Major Duties: Assists in drafting, assignment to vendors, and oversight of negotiation process for all manner of assigned research related agreements pertaining to clinical studiesOversees negotiations of proposed changes to standard contract language within guidelines provided by the Legal Division; raises significant requested changes to standard contract language to the Legal Division and significant budget exceptions to the appropriate management for considerationPrepares or directs the preparation of documents in connection with outsourcing of services for their responsible site such as: Letters of Indemnification, Investigator agreements, Amendments, and other similar documentsDemonstrates advanced understanding of legal concepts and principles as they relate to: Confidentiality, Service, Investigator and Consulting agreementsDemonstrates advanced understanding of study budgeting, negotiation tactics, project management, and drug development procesesProactively identifies operational process issues and collaborates with Team Lead to develop process solutions

Training & Education Preferred:BA or BS degree (preferably in a related discipline) and 2+ years of clinical trials experience, of which candidate has experience negotiating and drafting clinical trial-related agreements; or MBA, JD or other graduate's degree and experience in negotiating and drafting clinical trial-related agreementsExcellent oral/written communication skills a necessity; as well as excellent Customer Service skills and focusAn individual to negotiate Investigator Initiated Research AgreementsThis individual would ideally have a paralegal background3 or more years Pharmaceutical industry experience in negotiating Investigator Initiated Research based Consultantship or Service agreementsSome awareness concerning Intellectual Property issues and the resolution of sameKnowledge of the clinical development process; previous work history in clinical research and/or the negotiating and drafting of contracts within clinical researchDemonstrated effective influencing and negotiating, good interpersonal, leadership, and team player skillsProject management skills as related to clinical research processesCustomer focused and solution orientedStrong computer skills