Senior Clinical Site Contracts Analyst - FSP / Sponsor Dedicated

Parexel International Corporation

Southeast, Remote, United States of America

The Senior Clinical Contract Analyst serves as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements, Clinical Trial Agreements (CTAs), Ancillary Services Agreements, Consultant Agreements and other clinical contracts.

Primary Duties:Manage Clinical Contract and Nondisclosure Agreement (NDA) process for Global trials: 

  • Serve as a conduit between Clinical Operations and the Legal group for contract requests including Confidentiality Agreements, Clinical Trial Agreements, Ancillary Services Agreements, Consultant Agreements and other clinical contracts
  • Process all clinical contract requests and help facilitate early execution through the Contract Management System 
  • Serve as primary contact for the Client during contract negotiation phase
  • Perform consistent quality audits of work output and document knowledge base as needed
  • Maintain contract tracking on SharePoint site and other systems used to manage contract and budget files

Negotiate Clinical Site Contracts & Budgets For Sites Managed by Sponsor:

  • Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contract
  • Work closely with study teams to develop country budget templates tailored for each study
  • Negotiate and manage consistent site budgets that will assist in early site activation
  • Ensure consistency in site payment schedules and terms to facilitate the payment system
  • Respond to queries related to contracts and budgets
  • Manage the contract escalation process to appropriate individuals, as needed
  • Establish good customer relations with sites starting with the primary point of contact for budgets and contracts
  • Analyze contract trends using available tools and assist with developing team metrics with regard to contract timelines.

For Sites Managed by a Clinical Research Organization (CRO):

  • Review and approve the master Investigator Fee template developed by CRO for each study before distribution to sites
  • Manage the final execution of site clinical contracts handled by a CRO and track the contract process for each study with a CRO;
  • Serve as escalation point of contact for budget escalations from CRO; 
  • Provide contract/budget comments to CRO on an as needed basis; 
  • Respond to CRO queries for previously negotiated site contracts to ensure consistency with contract language and budget line items 


  • Develop written processes relevant to the scope of work listed above as needed
  • Contribute to team efforts for continuous process improvements
  • Adhere to Clinical Operations or project specific quality documents (e.g. SOPs, work practices, training guides), as applicable.
  • Participate in the development and testing of relevant tools and procedures
  • Workflow management
  • Complete training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, and system and process related training
  • Adhere to EP and Client SOPs and processes

Skills and Education:

*APAC experience is required

  • Bachelor’s degree in Life Science, Business or equivalent. MBA preferred
  • Minimum four (4) years of global experience working in a biotech or CRO, finance and/or business environment as a contract analyst/specialist
  • Experience negotiating contract payment terms and budgets
  • Intermediate Excel and database management skills 
  • Knowledge of GCP/ICH requirements 
  • Excellent analytical and problem solving skills
  • Requires effective organizational and communication skills 
  • Work both independently and ability to successfully work in a “virtual” team environment
  • Has a track record of exceeding goals successfully
  • Partners with others to get work done
  • Follows through on commitments
  • Shows personal commitment and takes action to continuously improve
  • Deals constructively with problems that do not have clear solutions or outcomes
  • Maintains a positive attitude despite adversity
  • Acquires data from multiple and diverse sources when solving problems


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