Site Contract Specialist II

About the role

We are seeking a Site Contract Specialist II to join our Clinical Solutions team. In this role, you will administer all contract management processes, collaborating with cross-functional teams to accelerate customer success in the life sciences industry. You will work in a fast-paced, agile environment, shaping solutions that drive impact for our customers and patients.

Responsibilities

• Administer all contract management processes, including coordination with protocol, informed consent, institution, investigator, vendor, consultant, and customer agreement documents at a project level.
• Lead (with supervision) multi-country projects, including negotiating and preparing contracts, budgets, and related documents for participation in industry-sponsored clinical trials.
• Provide support to SSUL to agree on country template contracts and budgets; produce site-specific contracts from the country template.
• Support submissions for proposed contracts and budgets for sites; negotiate budget and contract with sites via the Site Contracts Service Centre and SSUL with the Sponsor until resolution of issues.
• Perform quality control and arrange execution of Clinical Trial Agreements (CTAs), as well as archival of documents into repositories and capture of metadata.
• Review contracts for completeness and accuracy, ensuring corrections are appropriately made and documented.
• Support business development and represent Site Contracts/Site Start-Up (SSU) at internal or customer meetings.
• Work with Contract Managers and team members to actively manage ongoing contract issues and perform follow-up on outstanding contract matters.
• Generate amended contract and/or budget documents as necessary; prepare contract management documentation for projects and streamline contract/proposal or internal processes.
• Work within forecasted country/site contracting timelines, ensuring compliance and tracking milestone progress in the agreed-upon SSU tracking system in real time.
• Collaborate with internal and external legal, finance, and clinical operations departments, communicating and explaining legal and budgetary issues.
• Facilitate the execution of contracts by company signatories.
• Maintain contract templates, site-specific files, and databases.
• Train and mentor less experienced staff members on departmental Standard Operating Procedures (SOPs) and ensure the quality of team work products.
• Maintain and update training material for the site contract team.
• Act as a communication liaison between site contracts staff and internal/external customers, providing functional guidance and keeping teams aware of contract statuses or pending issues.
• Prepare correspondence as necessary.
• Monitor basic financial aspects of the project and the number of hours/tasks available per contract; escalate discrepancies in a timely fashion.
• Review and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) in a timely manner; keep training records updated and ensure timesheet compliance.
• Contribute to training and quality assurance plans within SSU and update SOPs/WIs.

Requirements

• BA/BS degree in Business Administration, Public Administration, Public Health, or a related field, or an equivalent combination of education and experience. Advanced degree preferred.
• High level of contracts management experience.
• Experience in a contract research organization or pharmaceutical industry is essential.
• Strong knowledge of the clinical development process and legal/contracting parameters.
• Strong computer skills in Microsoft Office Suite.
• Customer-focused with the ability to manage challenging priorities and remain flexible and adaptable in stressful situations.
• Excellent understanding of the clinical trial process across Phases II-IV and ICH GCP.
• Good understanding of clinical protocols and associated study specifications.
• Good understanding of clinical trial start-up processes.
• Project management experience in a fast-paced environment.
• Good vendor management skills.
• Excellent written/oral communication, presentation, documentation, and interpersonal skills, as well as a strong team orientation.
• Strong organizational skills with a proven ability to handle multiple projects.
• Quality-driven in all managed activities.
• Strong negotiating and problem-solving skills.
• Ability to mentor, lead, and motivate more junior staff.
• Demonstrated ability to provide quality feedback and guidance to peers.

About Syneos Health

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change, and accelerate progress. Over the past five years, we have worked with 94% of all Novel FDA-Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients. Our team of 25,000 colleagues is passionate about developing our people through career progression, supportive line management, technical and therapeutic area training, peer recognition, and a total rewards program. We are committed to building an inclusive culture where you can authentically be yourself, driven by our shared purpose to deliver solutions that dramatically impact patients' lives.