Clinical Operations Senior Contracting Specialist

United States of America, Indiana, Indianapolis

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Job Summary:

This role is part of CPS MSA Clinical Operations.  The individual will actively and strategically participate in a team responsible for delivering compliant, efficient, and legally-sound contracts (including negotiation, execution, management and other associated tasks), as well as budgeting and fair market value analysis and assessment of all materials and/or work performed.  It is additionally responsible for active participation in the management and collection of data for federal Sunshine Act reporting requirements.  Assistance with proactive improvement-seeking evaluation of departmental processes and input into the performance of any relevant software tool(s) is required.

What You Do:

  • Participate as a key member of a study team for diagnostic clinical trials, including the continuous development of skills and subject matter expertise to advise colleagues and internal business partners on any associated contractual (or other) risks.  Support may include visits to clinical trial sites.
  • Serve as a subject matter expert on both clinical and non-clinical contracts (including but not limited to Clinical Trial Agreements, SOWs, NDA/CDAs, etc.), and assist in contract negotiation, execution, management and other associated tasks.  Support shall also include site/vendor adds and purchase order creation for department.
  • Identify, investigate, and resolve or provide recommendations to resolve contract issues.  Assistance in the continuous management of contract compliance and best in class management of contract life-cycle.
  • Assist in the maintenance of data base(s) and/or software tool(s) utilized for global site selection and contract work flow progress, ensuring accurate, complete documentation of site/vendor capabilities, performance, post-study site evaluations, and contractual status.
  • Continuous active development of the departmental global investigator/site/vendor network, completed through thorough market analysis and research and conducted in a strategic way with a process-efficiency mindset.
  • Collect and report via applicable software tool(s) the required departmental study data/information for federal Sunshine Act reporting on a routine basis. Maintain federal Sunshine Act database in electronic system, as well as required reporting documents and records as needed.
  • Assist in the preparation of outgoing departmental RFPs, providing support to study teams and in collaboration with Procurement colleagues during related budget and contract negotiations.
  • Assist in the preparation of site/vendor budget templates, coordination of negotiation, and final review/acceptance.  Participate in and prepare fair market value data through thorough market analysis and research, using software tool(s) and/or a database management of historical numbers.
  • Foster cross-departmental and/or business partner relationships to aide in development of segment specific business policies that are responsive to department’s needs and Company’s risk mitigation needs.
  • Provide high quality global customer service for internal Clinical Operations teams, to include active participation in the creation/maintenance of an intranet site for internal reference and guidance.
  • Contribute to the development and maintenance of function guidance documents, workflows, SOPs, and the like.
  • Provide guidance and some oversight to junior staff and contract employees assisting in the processes.

Who You Are:

  • Bachelor’s Degree, preferably in life science
  • 5 years contracting experience, preferably in the life sciences industry 
  • Demonstrated contract administration and process knowledge including the impact and affect on business performance
  • Comprehensive computer skills including advanced MS Excel utilization and SAP
  • Demonstrated sound judgment and decision making
  • Comprehensive experience analyzing and solving business situations
  • Strong attention to detail

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