Clinical Operations

  • location: Northbrook, IL
  • type: Contract
  • salary: $76 - $89 per hour

job description

Clinical Operations

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Job Title: Project Management Resource II

Position Description

  • Person will provide structure and support to internal stakeholders and external providers for Medical Affairs sourcing activities within the Company M&D organization. Person will be a business partner implementing and supporting the Company strategy for external provider utilization, risk mitigation and compliance while ensuring value optimization. Person will be responsible for executing and managing all outsourcing and contracting activities for assigned projects to support Medical Affairs Late Phase Studies, Non-Interventional Studies, External Database Studies, and/or Health Economics and Outcomes Research (HEOR) activities.
  • In accordance with Company procedures and policies, Person will facilitate vendor sourcing for assigned studies, and books of work. Responsibilities include: preparation, distribution, and management of RFIs and RFPs, conducting bid defenses, vendor analysis to guide team decisions regarding outsourcing solutions, and leading negotiation of value with suppliers.
  • Person will draft and negotiate contracts for Medical Affairs activities using Company templates. Specifically including, but not limited to Services Agreements, Amendments, Work Orders, and Change Orders. Person will leverage experience, precedent, and processes to develop alternate contract language for consideration and approval, and ensure that contract terms are compliant with legal and corporate guidelines. Person will ensure that pricing (FSP, Fixed Price, Unit Price, Fee for Service, study budget etc.), and payment terms appropriately protect, are in the best interests of Company, are consistent and well defined, and are reasonable and customary.
  • Role will require management of multiple and simultaneous projects impacting Medical Affairs activities. Activities within this role include effectively communicating with assigned stakeholders, developing relationships with assigned stakeholders, and managing work load efficiently. Work on data or budget analysis may be required. Role may include other responsibilities as assigned.

Position Requirements

  • Required

    • Bachelor's Degree
    • Minimum 6 years of pharmaceutical or related industry contracts (investigator or vendor), outsourcing, or clinical development experience
    • Understanding of the drug development process
    • Proficient with analyzing rates and costing structures
    • Ability to work in a matrix environment
    • Ability to function autonomously with little supervision
    • Demonstrated ability to manage multiple projects simultaneously
    • Strong attention to detail and organization
    • Strong interpersonal skills, written, and verbal communication skills
    • Advanced use of word processing and spreadsheet software
    • Good decision and problem solving ability
    • Solid soft skills: customer service, sales, presentations, strong business partner
    • Working knowledge of various contract types and complexity levels
    • Proficient knowledge of clinical development financial principles including cash flow neutrality, payment schedules, costing systems, relational costs
    • Good time management, planning and scheduling skills
    • Team player, collaborative, relationship oriented
    • Fluency in English, both written and verbal
  • Preferred

    • Advanced degree (MBA, MS, JD, etc.)
    • Legal and business experience
    • Previous experience in CRO environment in proposal development, BD, or clinical operations
    • Proficiency with budgets and/or financial analysis tools and methods
    • Successful track record with metrics, project management
    • Experience in Medical Affairs
    • Understanding of non-interventional and external database study considerations
    • Experience working in a global team


  • Medical, Dental, and Vision Insurance
  • 401K Plan with Company Match
  • Life and AD&D Insurance

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