Contract and Budget Specialist II

Contracts and Budget Specialist II

Home Based in USA

As part of a global team you will be responsible for preparing country site budgets and study financial appendices, assisting with the negotiation of site agreement budgets and financial exhibits of a certain complexity.  

Responsibilities include:

• • Develop Clinical Trial Agreements (CTAs) utilizing standard templates and information from Contract Information Sheets. Ensure CTAs are executed in a timely manner in order to meet expected timelines for study start-up. Liaise with the legal departments to ensure any content changes to the CTAs are mutually agreeable, and in accordance with client's legally approved standard agreement language. Participate in Study kick-off meetings to obtain necessary information required for effective CTA execution
  • .Solid understanding  of  standard  contract  language  to  enable  decision  making  pertaining  to  sections  of  CTAs  when  language modifications are proposed by external contract parties.  If language is not compliant, discuss issues with legal and work with the legal department, sites, contractors or vendors to resolve them.
  • Generate  site  budgets  based  on  final  approved  country  budget  in  preparation  for  distribution  to  sites and  following  up  with investigators. Research medical procedure costs using local or global database in order to provide accurate data for development of the site level budgets to allow Country Lead Monitors/Study Managers to calculate the latest average costs on procedures for their new studies.
  • Manage CTAs ensuring all changes to agreements and corresponding components are updated according to client’s legal standards and  client Global  SOPs. 
  • Responsible  to  ensure  annual  review  of  all  templates  with  the  Legal  department  and  Local  Head  of Monitoring and Site Management
  • Manage the contract tracking database, including coordination of timely updates with respect to CTA. Ensure accuracy of information and reconcile discrepancies between documents and the database. Responsible for posting of fully executed contracts in eFiliA and locally on the Clinical Operations secure drive.
  • Process  for  each  study,  internal  approval  forms  and  other  documents  which  are  required  to  ensure  compliance  with  the  Internal Signatory Process and are also required for annual audits.
  • Ensure  excellent  communication  and  collaboration  as  point  person  among  clinical  trial  site  personnel  (Investigator,  Study Coordinator, Institution's Legal Counsel) client’s Head, Clinical Operations, Legal Counsel and Manager, Insurance, throughout the contract negotiation process.
  • Responsible for preparing for internal audits by maintaining a complete and accurate paper trail for each site contract negotiation.
  • Negotiate  Master  Services  Agreements  (MSAs)  with Institutions  where  Clinical Trials  have  been  conducted  and  ensure  they  are reviewed prior to their renewal dates

Education:

• Must have a Bachelors’ degree or an equivalent scientific or commercial Higher Vocational education 

Experience:

• Experience  in  the healthcare field, pharmaceutical industry or clinical research preferred.