Sr. Manager, Clinical Contracts and Outsourcing

Newark, CA 94560

Posted: 10/18/2018 Employment Type: Contract Industry: Clinical & Scientific Job Number: 14058

Sr. Manager, Clinical Contracts & Outsourcing

Position Summary:

The Sr. Manager, Clinical Contracts & Outsourcing will lead the contract process between the Clinical Operations/Development and internal and external business partners, supporting the outsourcing and contracting needs of clinical trials and development activities according to operational best practices and company standards.   This position will be responsible for the generation, negotiation and execution of clinical vendor contracts. The individual will coordinate and gather inputs from subject matter experts (Clinical Trial Managers, Clinical Finance, Legal, and Accounting) to ensure the contract terms, statement of work (SOW) and budget meet the needs of the clinical trial, financial guidelines, and corporate policies. This position will also be responsible for managing and facilitating any change orders to the SOW and playing a key role in developing and implementing standard contract management best practices and processes.

 

Responsibilities:
  • Lead and enhance Clinical Operation’ s & Clinical Development’ s internal contract procedures and serve as the primary contact between potential KOLs/vendors/investigational sites and functions including, but not limited to, Clinical Trial Managers, Clinical Finance, Legal, and Accounting
  • Obtain internal agreement on work to be outsourced for clinical trials and or development work
  • Coordinate with Legal to obtain the necessary agreement and budget templates for investigators, CROs, and vendors
  • As the primary contact, lead and coordinate subject matter experts in the Request for Proposal (RFP) process including vendor evaluation and selection, bid presentations and analysis, contract development, change orders and issues management. Facilitate third party vendor selection and SOW finalization. Route contracts for approval
  • Negotiate business terms and conditions for outsourced services working closely with Legal and Clinical Operations and other relevant functional groups
  • Negotiate site budgets & payment schedule with a sense of urgency
  • Perform quality check of all agreements, contracts, etc., to ensure agreement with the trial protocol/requirements, and consistency across contracts/vendors, financial guidelines, and corporate policies
  • Support Clinical Operations and Clinical Development on outsourcing and contracting needs on a daily basis. Drive and facilitate timely contract review by internal and external contacts, and track/coordinate the approval process. Field daily contacts from sites and vendors, and address contract/budget/payment issues in a timely manner. Provides routine reporting on the status of contracts to stakeholders
  • Represent Clinical Operations and Clinical Development in weekly contract status meetings with Legal and provide contract pipeline updates. Provide weekly contract status report to Clinical Operations Management
  • Participate in the development of departmental process and tools that streamline the outsourcing of clinical services. Partner with functional representatives to update and/or create standard templates for, e.g., contracts, RFPs, decision matrix, routing sheet, term sheet, and budget. Identify areas for improvement and recommend corrective actions
  • Provide necessary information for insurance coverage of the clinical trials; obtain license agreements
  • If situation calls for it, step up to proactively collaborate with cross functional departments within Clinical Development to report vendor accruals. Perform cost trend analysis
  • Partner with Clinical Operations Management in developing successful vendor partnerships
  • Deliver training to functions and new employees on outsourcing and contracting processes
  • Perform other duties as required 

 

Preferred Experience:
  • BA/BS degree in life sciences or in Business Administration, Finance, Accounting, or similar field, required
  • 5+ years of contract management  level expertise in a clinical research setting with an understanding of the contract process for phases 1-4 clinical trials & IITs
  • Excellent negotiation skills and strong attention to detail
  • Strong verbal and written communication skills and computer skills
  • Proficiency with MS Office applications: Excel, Word, Adobe Acrobat
  • Experience with databases
  • Experience with clinical accruals, site payments & vendor cost reconciliation
  • Self-starter with ability to exercise judgment to make decisions for less defined issues and selects methods and techniques for obtaining solutions
  • Excellent organizational skills with strong project management capabilities in ability to plan/schedule job activities to meet priorities and communicate status to set expectations
  • Ability to interact with a wide range of people and build strong positive relationships in a cross-functional environment
  • Ability to work in a team as well as independently, and to manage multiple priorities with minimal support in a fast pace environment
  • High customer orientation awareness and focus

Jesse Ashworth

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