Budgets Specialist II, Site Agreements, FSP

<h2>Job Overview:</h2><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong>Sr. Contract and Budget Specialist </strong></span></p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Home Based</span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Labcorp Drug Development  has an excellant remote opportunity for a Budgets Specialist II, Site Agreements located anywhere within the United States.  </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">This individual will be responsible for following SOPs, managing assigned country budget related activities in accordance with our compliance and internal processes, and managing specific financial aspects of our clinical studies including but not limited to supporting Project Directors with post-award study budget estimates and review of proposals.  </span></p><p style="margin: 0px;"> </p><p style="margin: 0px;"><span style="font-family: arial, helvetica, sans-serif; font-size: 10pt;">Other responsibilities include:</span></p><ul><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">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.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Thorough understanding of standard contract language to experience making decision 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.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Generates  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.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Manages CTAs ensuring all changes to agreements and corresponding components are updated according to client’s legal standards and client’s global SOPs </span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Responsible  to  ensure  annual  review  of  all  templates  with  the  Legal  department  and  Local  Head  of Monitoring and Site Management</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Manages  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.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">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.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">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.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Responsible for preparing for internal audits by maintaining a complete and accurate paper trail for each site contract negotiation.</span></li><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Negotiate Master Services Agreements (MSAs) with Institutions where Clinical Trials have been conducted and ensure they are reviewed prior to their renewal dates</span></li></ul><p style="margin: 0px;"> </p><p style="margin: 0px;"> </p><h2>Education/Qualifications:</h2><ul><li><p style="margin: 0px;"><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">Must have a Bachelors’ degree or an equivalent scientific or commercial Higher Vocational Education l</span></p></li></ul><h2>Experience:</h2><ul><li><span style="font-size: 10pt; font-family: arial, helvetica, sans-serif; color: black;">At least 3 years’ experience in contract and budget management within the healthcare field, pharmaceutical industry or clinical research</span></li></ul>