Senior Site Contracts Lead

Senior Site Contracts Lead

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

• Establishes, maintains and updates training material for site contracts lead team and site contract negotiators.

• Serves as subject matter expert within the organization equipped to help resolve global site contracting issues, and escalation point within the Company for internal customers to seek assistance.

• Oversees negotiations of clinical study agreements (CTA´s) on a study level and drives CTA document finalization and execution, including contractual language & terms, financial attachments, and investigator grant budgets in collaboration with a global team of site contract & budget negotiators.

• Provides oversight of contact & budget negotiations status and manages escalation of out-of-parameter queries on budgetary and contractual requests to sponsor decision-makers in all regions of study conduct. Provides consultation during escalation of out-of-parameter queries as needed.

• Advises study team and Sponsor stakeholders on industry trends, norms, and emergent developments surrounding site contract and budgetary negotiations. Provides consultation on potential risks and mitigation tactics for negotiation issues pertaining to overall study start-up needs.

• Acts as first-line subject matter expert for all such CTA elements on assigned studies for internal and sponsor stakeholders alike. Advises stakeholders on issue resolution within the context of assigned studies. May seek additional support from internal support structures as needed.

• Plans contract execution strategy for assigned studies—including forecast of site-specific contractual execution timelines with as much accuracy as possible—and coordinates with internal study team stakeholders to ensure that CTA strategy is aligned with overall study start-up plans and expectations overall. Manages expectations of internal and sponsor study team regarding global CTA negotiations for assigned studies.

• Coordinates communications between study team stakeholders and global team of site-facing site contract & budget negotiators including roll-up of all status updates to regular team forum. Participates in regular study calls to facilitate communication as needed.

• Works closely with internal stakeholders and with Sponsor to prepare site contractual templates, including payment terms, and study-level negotiation parameters and processes within Company standards in order to drive successful negotiation of contracts and budgets.

• Establishes strong working relationships and collaboration with Sponsor to ensure site contractual templates fit into the global strategy set for the program.

• Identifies possible site contractual and investigator budgetary document or process operational risk and proactively works to provide solutions. Establishes strong working relationships with customer and internal project teams. Escalates deviations to senior management and is equipped to resolve issues with Quality Assurance.

• Creates and maintains document status reports, and updates department tools/systems and team members on a regular basis; ensures appropriate documentation is maintained.

• Collaborates with internal and external legal, finance and clinical operations departments, including communicating and explaining legal and budgetary issues.

• Manages site and study level discussions with internal and sponsor team stakeholders around fair market value of investigator budgets and payment terms within corporate and industry standards during negotiation with sites.

• Identifies best practices, investigates root causes of fundamental issues and problems for projects and recommends solutions.

• Trains and mentors less experienced staff members on department Standard Operating Procedures (SOPs), processes, tools and templates and ensures quality of teamwork products.

• May support BU and organization through help desk and other defined pathways to resolve and deescalate issues.

• May identify and lead internal team training and/or process improvement initiatives.

• Participates in business development presentations as a subject matter expert in site contracts and investigator budget management within the Company

• Performs other work-related duties as assigned.

Minimum Qualifications

• BS degree in life sciences, a health related field, or equivalent combination of education and experience.

• Preferred experience in a CRO/pharmaceutical industry and related clinical trial expertise (Study Coordinator, CRA, Pharmacy, Nursing, Healthcare Administration) or site start-up experience.

• Thorough knowledge of applicable regulations, drug development and clinical project management procedures.

• Good presentation, documentation and interpersonal skills. Proficient in MS Office (Word, Excel and PowerPoint), MS Project, outlook and Internet.

• Ability to handle multiple tasks to meet deadlines, delivering high quality work in a dynamic environment.

• Attention to attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines. Strong leadership skills; ability to teach/mentor team members.

Preferred Qualifications

• 6+ years of site contracts and study start-up (SSU) experience within a global CRO or pharmaceutical sponsor environment, including ownership of multi-country studies.

• Demonstrated expertise negotiating site CTAs and investigator budgets, including direct interaction with sites, sponsors, Site Contract Service Centers, and Legal teams.

• Strong experience drafting and managing site-specific CTAs from country or global templates and ensuring alignment with sponsor MSAs and country requirements.

• Proven ability to manage contract amendments and protocol-driven changes, maintaining compliance with timelines, quality standards, and documentation requirements.

• Experience serving as an escalation point for complex contract, budget, or process issues, with a track record of proactive risk identification and resolution.

• Hands-on experience with SSU tracking systems and contract repositories, including real-time milestone tracking and metadata management.

• Demonstrated leadership in training and mentoring junior staff, including contribution to SOPs, WIs, templates, and internal training materials.

• Experience supporting business development activities, such as proposal development, bid defenses, or sponsor-facing meetings.

Location

• Open to US-Remote candidates

Salary

• 67,700 - 115,100

At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.

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.

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.

Summary

Roles within the Site Start-Up/Site ID job family are responsible for managing and executing the site identification process in accordance with regulations, SOPs, and project requirements. This includes completing and negotiating site confidentiality agreements (CDAs) and site information forms (SIFs) with sites, maintaining, reviewing, and reporting on site performance metrics, serving as the primary point of contact for investigative sites, and tracking the completion of site identification for sites. Impact and Contribution Individual contributors with responsibility in a professional or technical discipline or specialty, but may manage two or fewer employees. May direct the work of lower level professionals or manage processes and programs. The majority of time is spent contributing to the design, implementation or delivery of processes, programs, and policies, using knowledge and skills typically acquired through advanced education. Established and productive individual contributor. May manage defined components of projects or processes within area of responsibility. Requires practical knowledge of a professional area, typically obtained through education combined with experience.