Site Contract Specialist/Contract Manager (CM) - Sponsor Dedicated/Remote-U.S. Only
Syneos Health
Summary
The Contract Manager is responsible for independently managing clinical trial agreements, amendments, and site budget negotiations. They will also collaborate with internal and external stakeholders to ensure contract execution and site activation timelines are met.
Job description
General Responsibilities
- 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.
Requirements
- Bachelor's degree in Business, Public Health, Life Sciences, or a related field (or equivalent experience).
- Demonstrated experience independently managing Clinical Trial Agreements (CTAs).
- Demonstrated experience independently managing CTA Amendments.
- Demonstrated experience independently managing Site budget negotiations.
- Demonstrated experience independently managing Contract lifecycle management with minimal oversight.
- Strong understanding of CTA drafting and negotiation.
- Strong understanding of Contract templates and fallback language.
- Strong understanding of Budget development and negotiation strategies.
- Strong understanding of Clinical trial start-up processes.
- Experience maintaining negotiation status and documentation within Sponsor or internal 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.
- Minimum of one (1) year of direct site contract and budget negotiations within CRO, site or pharma company required.
Benefits
- Company car or car allowance
- Medical, Dental & Vision
- 401(k) Matching
- Employee Stock Purchase Plan
- Commissions
- Bonus
- Flexible PTO
- Sick Time
Company overview
Syneos Health is a leading fully integrated biopharmaceutical solutions organization that accelerates customer success by translating unique clinical, medical affairs, and commercial insights into tangible outcomes. The company provides comprehensive clinical development services spanning Phase I to Phase IV trials, including full-service global studies, clinical monitoring, patient recruitment, investigator recruitment, and data management. Additionally, Syneos Health offers commercial solutions such as communications, medication adherence programs, and consulting services. With over 26,000 employees worldwide, including more than 480 MDs and 750 PhDs, the organization supports biopharmaceutical companies across all stages of drug development and commercialization. Syneos Health has helped develop or commercialize 93% of novel drugs approved by the FDA and 90% of products granted marketing authorization by the EMA in the last five years, demonstrating its significant impact on bringing important therapies to patients globally.