Clinical Contract Manager

Princeton, NJ
Full Time
Mid Level
The Contract Manager is responsible for driving site contract and budget negotiations with sites participating in SystImmune clinical trials. This is included but not limited to Sites’ proposed changes to standard contract terms and the study-specific budget parameters (in partnership with other business lines internally), ensuring the delivery of high quality, compliant, effective, and timely site contracts, and maintaining productive relationships with internal stakeholders.
Key Responsibilities
  • Accountable for negotiating clinical contracts within timelines with sites and HCPs
  • Address changes to study scope to ensure timely contract amendments during the duration of Clinical Trials
  • Build Site facing budgets and parameters by developing or utilizing industry benchmarking
  • As a member of cross-functional study team, lead appropriate agenda topics of the SSU meetings as related to clinical contracting
  • Single point of contact for internal stakeholders, and CROs, when applicable and sites for assigned studies Provide subject matter expertise for assigned therapeutic areas
  • Accountable for ensuring that performance and efficiency standards are met for assigned studies
  • Assist with updating SystImmune’s site contracting processes
  •  Engage with the study teams from early planning throughout the end-to-end contracting lifecycle
  • Work closely with internal stakeholders, and CROs and effectively communicate, in order to ensure that business objectives are met (e.g., scheduled site initiation visit deadlines)
  • Handle site contracting related escalations from the CROs and/or the investigator sites, effectively and efficiently
  • Develop and enhance relationships with, internal stakeholders, CROs, and sites
  • Partner with colleagues at external law firms, under the guidance of the Senior Director and other stakeholder groups, as needed, to continuously enhance SystImmune’s  Contract templates and tools
  • Ensure that internal systems are updated in a timely, accurate, and complete manner
  • Meet with study teams regularly and prioritize assignments
  • Stay abreast of changes in industry standards and help identify new best practices to contribute to continuous improvement
  •  Help train others on site contracting processes and industry practices
  •  Manage changes to study scope, ensuring timely contract amendment and implementation
Qualifications
  • Minimum of 5 years of relevant experience in clinical site contracting at a biopharmaceutical company, Clinical Research Site, or CRO.
  • Strong negotiation skills.
  • Excellent verbal and written communication in English.
  • The ability to thrive in a fast-paced work environment.
  • Paralegal Certification or Bachelor’s Degree in a scientific discipline, law, finance, or related field. 
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