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We know just how important it is to put people first. It's with that human touch that we've played a part in nearly all of the top 50 treatments on the market. And every day, we're focused on working with industry leaders to bring life-changing healthcare to patients across the globe. Whether you join our Clinical, Consulting, Biotech, Functional Service Provider (FSP), or other teams, we're doing it With Heart ™.

Sr. Clinical Contract Analyst - FSP

Job ID 75335BR USA - Any Region - Home Based
About ExecuPharm

ExecuPharm is the North American clinical operations business within Parexel FSP. We provide biopharmaceutical companies with qualified and talented professionals to accelerate the development and delivery of new therapies.
For results-driven and caring individuals who want to make a meaningful difference in the world, Parexel is the CRO trusted by life sciences companies to innovate keeping patients at the center of everything we do, and where an inclusive global community helps you be your best, transforming any career into a life-changing achievement.
  • Manage Clinical Contract and Nondisclosure Agreement (NDA) process for Global Trials
  • Serve as legal liaison for clinical contract requests such as, NDA’s, CTAs, Service Agreements, and Ancillary Agreements and act as conduit between CDO and the Legal group
  • Process all clinical contract requests and help facilitate early execution through the Contract Management System
  • Perform consistent quality audits of work output and document knowledge base as needed
  • Maintain accurate contract metrics on an ongoing basis.
  • Serve as primary contact for the Client during contract negotiation phase
  • On-going interface with sites and vendors regarding contractual issues during the lifetime of the contract
  • Establish and maintain direct site and vendor contact
  • Negotiate Clinical Site Contracts & Budgets

For Sites Managed by the Client:

  • Manage and own the contract process through its lifecycle from initial template stage to fully negotiated contract
  • Work closely with study teams to develop a budget template tailored for each study
  • Negotiate and manage consistent site budgets that will assist in early site activation
  • 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

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

  • Review and approve the investigator fee template per country for each study before distribution to sites
  • Be a conduit for the contract request to the Client Legal team from initial contract request through execution for 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;
  • Respond to CRO queries to ensure consistency with contract language and budget line items in accordance with Client standards
#INFSP

Qualifications

  • Bachelor’s degree in Life Science, Business, Legal or equivalent
  • Minimum of two (2) years experience working in contract management, proposal development or related field in a biotech or CRO, finance and/or legal environment

This role may be subject to government and/or customer requirements regarding vaccination against COVID-19 that are more stringent than Parexel policy. Accordingly, successful applicants may need to be either vaccinated against COVID-19 or have an approved religious or medical exemption. Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

EEO Disclaimer

Parexel is an equal opportunity employer.  Qualified applicants will receive consideration for employment without regard to legally protected status, which in the US includes race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

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