Senior Clinical Contracts Manager - Remote

Rockville , MD
Mar 18, 2023
Apr 04, 2023
Full Time
Westat is an employee-owned corporation providing research services to agencies of the U.S. Government, as well as businesses, foundations, and state and local governments. Westat's research, technical, and administrative staff of more than 2,000 is located at our headquarters in Rockville, Maryland, near Washington, DC.

Westat is committed to building a diverse workforce and a culture of inclusivity, belonging and equity for all. We believe that our greatest strength draws on the different backgrounds, cultures, perspectives and experiences of our employees.

Westat is seeking a Senior Clinical Contracts Manager to join its fast paced Contracts team.   In this role, you will be working on commercial and federal clinical research and clinical trial projects. This position will support the full life-cycle of contract management activities.

Job Responsibilities:
• Draft, negotiate and review complex contracts related to clinical research studies and clinical trials including Clinical Site Agreements, Master Services Agreements, NDAs, MTAs, DTA/DUA/BAAs, Subcontractor and Vendor Agreements.
• Oversee vendor and subcontractor negotiations.
• Administer pre and post award activities related to government and commercial sponsored clinical trials including overall management and monitoring of agreements with external partners.
• Ensure contractual documents sufficiently meet regulatory obligations and company policies and procedures.
• Perform contractual risk assessments.

Basic Qualifications:
• Typically requires a Master's degree or equivalent experience
• 10 years contracts experience with a minimum of 5 years clinical trial contracts experience.
• Knowledge of the FAR and FDA regulations

Preferred Qualifications:
• Master's Degree or JD
• Experience with federally funded clinical projects and/or HHS sponsored clinical research
• Experience working on commercial clinical projects
• Knowledge of GCP and GDPR
• Experience with SharePoint and Deltek products

Minimum Qualifications:
• Demonstrated communication skills
• Collaboration with teams, managers and/or clients
• Organization skills, including time management ability
• Detail oriented

Westat offers a well-rounded and comprehensive benefits program focused on wellness and work/life balance. Eligible employees may participate in:
  • Employee Stock Ownership Plan
  • 401(k) Retirement Plan
  • Paid Parental Leave
  • Vacation Leave (15 days per year)
  • Sick Leave (10 days per year)
  • Holiday Leave (7 government holidays and 2 floating holidays)
  • Professional Development
  • Health Advocate
  • Employee Assistance Program
  • Travel Accident Insurance
  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • Short Term Disability Insurance
  • Long Term Disability Insurance
  • Life and AD&D Insurance
  • Critical Illness Insurance
  • Supplemental Life Insurance
  • Flexible Spending Account
  • Health Savings Account


Westat is an Equal Opportunity Employer and does not discriminate on the basis of race, creed, color, religion, sex, national origin, age, veteran status, disability, marital status, sexual orientation, citizenship status, genetic information, gender identity or expression, or any other protected status under applicable law.

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