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Clinical Research Outsourcing Manager

Cambridge, Massachusetts 02139

Post Date: 03/08/2018 Job ID: 1834 Job Category: Clinical: Clinical Operations and Development

We are seeking a highly skilled Clinical Research Outsourcing Associate/Manager to assist with all aspects of the contract process from vendor selection through execution and close out of the contract.  As a member of the Clinical Operations team, you will be able to work alongside passionate and innovative team members who will support you in your role. 

Job Responsibilities:
  • Initiating and managing the Request for Proposal (RFP) process for clinical research and development vendors, including full-service CROs, central laboratories, specialty laboratories, ePRO, EDC and other Data Management providers, biostatistics and central imaging
  • Developing and negotiating SOWs and contracts with input from the clinical teams based on needs of protocol
  • Supporting any contract amendment required throughout the study
  • Reporting contract and budget status to management, responsible for oversight of Agreement Tracker
  • Working with the clinical teams to manage out of scope activities and change orders
  • Liaising with legal department to drive contract negotiations in timely fashion
  • Liaising with finance department to ensure they have information needed to provide accurate forecasts and accruals
  • Establishing relationships with vendors and serving as a key liaison with internal and/or external team members, regarding all contract related issues

Qualifications/ Requirements:
  • Bachelor’ s degree required
  • Minimum of 3 years in clinical research outsourcing and RFP management in a pharmaceutical, biotechnology and/or CRO organization
  • Demonstrated proficiency in management of multiple contracts for multiple clinical programs, budget tracking and ability to work with multiple departments
  • Extensive knowledge of clinical trials in all phases and clinical vendors, including CROs is essential
  • Experience with mid-study changes
  • Experience reviewing contract language
  • Extensive experience negotiating budgets with clinical vendors
  • Must have the ability to read and understand a protocol and determine outsourcing needs of a particular protocol
  • Knowledge of clinical outsourcing and familiarity with major vendors
  • Understanding of fair market value and how budgets are developed
  • Proficiency in MS Word and Excel is required

Anna Korelis

Anna is a creative problem solver who prides herself on her strong work ethic and expert communication skills. Goal-oriented and service-driven, Anna has a keen eye for the skills that enable her candidates to stand out, and digs deep to understand what motivates them to find their next opportunity.

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