Site Contracts Specialist - Clinical Trials (Home-Based)

About the role

Syneos Health is hiring a Site Contracts Specialist for a home-based, remote position open to candidates located anywhere in the United States. The role covers contract negotiation, preparation and management for industry-sponsored clinical trials, with emphasis on experience in clinical trials and home-based arrangements in Mexico, Brazil and Argentina.

Key responsibilities

• Negotiate and prepare contracts, budgets and related documents for participation in industry-sponsored clinical trials, and produce site-specific contracts from the country clinical trial agreement (CTA) template.
• Submit proposed CTAs and investigator budgets for site review, and negotiate budget and contract with sites and the Site Contracts Service Centre until issues are resolved.
• Perform quality control, arrange execution of CTAs, archive documents and capture metadata, and review contracts for completeness and accuracy.
• Administer contract management processes, coordinate with protocol, informed consent, institution, investigator, vendor, consultant and customer agreements, and generate amended contract and budget documents.
• Work with the Site Contract Service Centre and Legal to align site contracts with the sponsor's master service agreement terms, and with Clinical Operations and Finance to validate budget loads and backlogs.
• Identify contract or process risks, escalate deviations, support business development, and represent site contracts and Site Start-Up at internal or customer meetings.
• Track milestone progress in the SSU tracking system, monitor basic financial aspects of projects, and ensure compliance with SOPs, work instructions and timesheets.
• Maintain contract, budget and site-specific file templates, train and mentor junior staff, and contribute to quality assurance plans and SOP updates.

Required profile

• BA/BS degree in Business Administration, Public Administration, Public Health or a related field, or equivalent education and experience; advanced degree preferred.
• Moderate contracts management experience, preferably in a contract research organization or pharmaceutical industry; management experience preferred.
• Excellent understanding of clinical trial start-up processes and of clinical trials in phases II-IV under ICH GCP.
• Good understanding of clinical protocols and study specifications, and of the clinical development process and its legal and contracting parameters.
• Project management experience in a fast-paced environment, strong organizational and vendor management skills, and ability to mentor junior staff.

Required skills

• Strong knowledge of Microsoft Office Suite.
• Strong negotiating, problem-solving and communication skills.

What we offer

• Annual base salary ranging from $56,000 to $95,000, depending on qualifications and experience.
• Career development, training and a total rewards program.