Careers

Operations Manager

Full-Time

Job Description

Be responsible for delivering compliant, efficient and legally-sound contracts as well as budgeting and assessment of all materials and/or work performed in all sites.

Responsibilities and Duties

  • Serve as the SME on both clinical and non-clinical contracts (including but not limited to Clinical Trial Agreements, SOWs, NDAs)
  • Take the lead in contract negotiation, execution, management and other related tasks.
  • Identify, investigate and resolve or provide recommendations on contract issues; ensure contract compliance and best in class management of contract life cycle
  • Prepare all site/ vendor budget templates, negotiation and final review/ acceptance; Prepare fair market value data through thorough market analysis and research, using software tools and/or database management of historical numbers
  • Prepare all outgoing RFPs (request for proposals), providing support to study teams and to collaborate with colleagues during related budget and contract negotiations
  • Provide high quality customer service for internal site management team, to include active participation in the creation/ maintenance of a documentation system
  • Foster cross-departmental and/or business partner relationships to aide in the development of segment specific business policies that are responsive to department’s needs and company’s risk mitigation needs
  • Contribute to the development and maintenance of function guidance documents, workflows, SOPs, etc

Qualifications

  • Graduate of any science-related course
  • At least 5 years contracting experience, preferably in the life sciences/pharma industry
  • Experience working in a Contract Research Organization (CRO)
  • GCP Knowledge and Training
  • ICH Guidelines

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