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.
 
Discover what your 25,000 future colleagues already know:
 
Why Syneos Health
• 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. Central to this is our purpose – Driven to Deliver – which 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. Why? Because 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. 

Job Responsibilities

Required Qualifications:

• Bachelor's degree in Business, Public Health, Life Sciences, or a related field (or equivalent experience).
• Demonstrated experience independently managing:
  • Clinical Trial Agreements (CTAs)
  • CTA Amendments
  • Site budget negotiations
  • Contract lifecycle management with minimal oversight
• Strong understanding of:
  • CTA drafting and negotiation
  • Contract templates and fallback language
  • Budget development and negotiation strategies
  • Clinical trial start-up processes
• Experience maintaining negotiation status and documentation within Sponsor clinical trial tracking systems.
• Excellent understanding of Phase II-IV clinical trials, ICH-GCP, and clinical development processes.
• Strong project management, organization, and prioritization skills.
• Exceptional negotiation, communication, and relationship-building abilities.
• Proficiency with Microsoft Office Suite.

Preferred Qualifications:

• Previous experience supporting a Sponsor-Dedicated/FSP model.
• Leadership or mentoring experience (Senior level).
• CRO experience.
• Experience supporting process improvement initiatives within Site Start-Up or Site Contracts.

• Review contract language and budgets for completeness and accuracy, and ensure that corrections are appropriately made and documented.
• Maintain internal project trackers with accurate and timely information to support overall transparency.
• Leverage fallback language provided by sponsor legal to effectively and accurately negotiate site contracting language.
• Negotiate Study budget utilizing the approved budget (medium and high) within approval parameters before escalation is required. Follow appropriate escalation pathway and processes.
• Attend weekly internal and external progress meetings and provide updates and next steps on active contract negotiations.
• Collaborate with primary stakeholders to ensure goals and priorities are aligned as it relates to contract execution date and site activation timelines.
• Establish and maintain positive working relationships with internal and external stakeholders throughout negotiating process.
• Identifying contractual or operational risks early and proactively driving solutions.
• Prepares Contract and Budget Escalations as required.
• Responsible for drafting and finalizing documents for Studies-start up (templates, Start up plans, etc.).
• Responsible for preparing and leading the Kick-Off Meeting with the Study Team.
• Responsible for scheduling other contract and budget prep and overview meetings. 
• Responsible for preparing the final contracts (once negotiations are complete and escalations approved).
• Participate in pilot and stretch projects as they align with role and sponsor initiatives. 

Get to know Syneos Health

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. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive.  The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description.  The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above.   Further, nothing contained herein should be construed to create an employment contract.  Occasionally, required skills/experiences for jobs are expressed in brief terms.  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.