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About the Role

Syneos Health is a leading life sciences services organization that partners with innovators to accelerate drug development and commercialization. The Clinical Solutions team applies deep expertise to understand customer needs and shape solutions. Team members collaborate in agile, driven environments to help customers achieve their goals.

Responsibilities

• Lead multi-country projects, including negotiating and preparing contracts, budgets, and related documents for clinical trials.
• Produce and review site-specific contracts from country templates, submitting proposed CTAs and investigator budgets for site review.
• Negotiate budgets and contracts with sites, resolving issues with the Site Contracts Service Centre and SSUL.
• Perform quality control, arrange CTA execution, and archive documents into repositories.
• Review contracts for completeness and accuracy, ensuring corrections are made and documented.
• Administer contract management processes, coordinating with relevant protocol, informed consent, and other agreement documents.
• Generate amended contract and/or budget documents as necessary, streamlining processes and introducing creative solutions.
• Collaborate with Site Contract Service Center and Legal to harmonize site contracts with sponsor's master service agreement terms.
• Work with SSU lead, Clinical Operations, and Finance to validate departmental budgets and backlog.
• Identify and proactively solve contract or process operational risks.
• Establish strong working relationships with SSU lead, customer, and internal project teams.
• Escalate deviations to department leadership, Site Contract Service Center, or Legal Department.
• Support business development and represent site contracts/Site Start-Up (SSU) at internal or customer meetings.
• Work within forecasted country/site contracting timelines and track milestone progress in the SSU tracking system.
• Collaborate with internal and external legal, finance, and clinical operations departments, communicating legal and budgetary issues.
• Maintain and support the review and development of contract templates, budget templates, and site-specific files and databases.
• Serve as a key communication liaison between site contracts staff and internal/external customers, providing functional guidance and status updates.
• Train and mentor less experienced staff on departmental SOPs, ensuring quality of work products and updating training materials.
• Participate in discussions about company goals, departmental objectives, and project aims.
• Facilitate the execution of contracts by company signatories.
• Monitor basic financial aspects of projects and available hours/tasks per contract, escalating discrepancies.
• Review and comply with SOPs and Work Instructions, keeping training records updated and ensuring timesheet compliance.

Requirements

• BA/BS degree in Business Administration, Public Administration, Public Health, or related field, or equivalent combination of education and experience.
• Moderate 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/contracting parameters.
• Strong computer skills in Microsoft Office Suite.
• Customer-focused with the ability to manage challenging priorities and remain flexible 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.
• Ability to mentor and motivate more junior staff.
• Demonstrated ability to provide quality feedback and guidance to peers.
• Contribute to a training and Quality Assurance plan within SSU and update SOPs/WI.

Skills

• Contracts Management
• Clinical Development Process
• Legal and Contracting Parameters
• Microsoft Office Suite
• Customer Focus
• Managing Challenging Priorities
• Flexibility and Adaptability
• Clinical Trial Process (Phases II-IV)
• ICH GCP
• Clinical Protocols
• Study Specifications
• Clinical Trial Start-Up Processes
• Project Management
• Vendor Management
• Organizational Skills
• Handling Multiple Projects
• Communication
• Presentation Skills
• Interpersonal Skills
• Negotiating Skills
• Problem-Solving
• Mentoring
• Motivating Junior Staff
• Feedback and Guidance
• Training Plan Development
• Quality Assurance
• SOP/WI Updates

Experience Level

• Moderate contracts management experience
• Management experience preferred

Education Level

• BA/BS degree in Business Administration, Public Administration, Public Health, or related field, or equivalent combination of education and experience.
• Advanced degree preferred

About the Company

• 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.
• Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
• Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals.
• We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.
• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.
• Our purpose – Driven to Deliver – captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with.
• We know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.
• Over the past 5 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.
• No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Equal Opportunity

• Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
• The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.