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Job Summary:

We are seeking a highly skilled Senior Contracts Specialist to join our team at Syneos Health Clinical. As a key member of our Clinical Operations department, you will play a critical role in negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.

Key Responsibilities:

  • Negotiate and prepare site-specific contracts from country clinical trial agreement (CTA) template, ensuring accuracy and completeness.
  • Collaborate with Site Contract Service Center and Legal to harmonize site contract to reflect sponsor's master service agreement terms.
  • Work closely with SSU lead, Clinical Operations, and Finance to validate departmental budgets and corresponding backlog.
  • Identify potential contract or process operational risks and proactively work with the team to provide solutions.
  • Establish strong working relationships with internal and external stakeholders, including customers and project teams.
  • Provide support to business development and represent site contracts/Site Start-Up (SSU) at internal or customer meetings.
  • Collaborate with internal and external legal, finance, and clinical operations departments to communicate and explain legal and budgetary issues.
  • Maintain and actively support review and development of contract templates, budget templates, and site-specific files and databases.
  • Train and mentor less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensure quality of team work products.
  • Actively participate in higher-level discussions about overall company goals, departmental objectives, and specific project aims.

Requirements:

  • BA/BS degree in Business Administration, Public Administration, Public Health, or related field, or equivalent combination of education and experience.
  • Modest contracts management experience, including experience in a contract research organization or pharmaceutical industry.
  • Management experience preferred.
  • Strong knowledge of the clinical development process and legal and contracting parameters.
  • Strong computer skills in Microsoft Office Suite.
  • Customer-focused and ability to manage challenging priorities and remain flexible and adaptable in stressful situations.
  • Excellent understanding of clinical trial process across Phases II-IV and ICH GCP.
  • Good understanding of clinical protocols and associated study specifications.
  • Excellent understanding of clinical trial start-up processes.
  • Project management experience in a fast-paced environment.
  • Good vendor management skills.
  • Strong organizational skills with proven ability to handle multiple projects.
  • Excellent communication, presentation, and interpersonal skills.
  • Quality-driven in all managed activities.
  • Strong negotiating skills.
  • Strong problem-solving skills.