Principal Site Contracts Lead Remote-US

1001 Syneos Health, LLC; North Carolina; Hybrid; USD 80,000 - 140,000; Full time

Benefits offered by this job

Company car or car allowance

Health benefits

401(k) match

Employee Stock Purchase Plan

Bonus eligibility

Job summary

Syneos Health is seeking a Principal Site Contracts Lead (Remote-US) to manage negotiation of clinical study agreements, finalize and execute contract terms, and collaborate with a global team of site contract negotiators.

The role requires extensive CRO/pharma experience, strong leadership, and expertise in regulatory aspects of site contracts and budgets. Remote work from the US is supported, with strategic collaboration across regions.

Qualifications

• BS degree in life sciences or related field; equivalent combination accepted.
• Extensive CRO/pharma industry clinical trial experience.
• Thorough knowledge of regulations, drug development and clinical project management.
• Excellent presentation, documentation and interpersonal skills.
• Proficient in MS Office; ability to manage multiple tasks and deadlines.
• Strong leadership and mentoring abilities.

Responsibilities

• Oversee negotiation of CTAs at study level and drive finalization and execution.
• Develop and update training materials for site contracts team.
• Advise sponsors and internal teams on negotiation trends and risks.
• Collaborate with internal and sponsor stakeholders to align CTA strategy with study start-up.
• Coordinate communications among global site contract and budget negotiators.

Skills

Leadership

Presentation

Interpersonal skills

Time management

Problem solving

Mentoring/Coaching

MS Office

Education

BS degree in life sciences or related field

Tools

MS Office

Job description

Principal Site Contracts Lead Remote-US 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

Job Summary: Manages negotiation 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 negotiators for Site Contracts Service Center for awarded projects. Ensures global CTA negotiation comply with sponsor and Company requirements. Identifies project and/or Company level investigator budget related problems, and works with internal and external team members to provide and implement solutions. Establishes strong working relationships with customers and internal project teams. Supports global operational initiatives at the project, Sponsor or relationship level. May serve as strategic point of contact for internal and external customers to meet site contracting/budgeting goals.

Core Responsibilities

• Establishes, maintains and updates training material for site contracts lead team and site contract negotiators.
• Actively participates in higher-level discussions about overall company goals, functional objectives in the Business Unit (BU), and specific project aims.
• 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.
• Represents the Company at professional meetings or seminars.
• 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.

Qualifications

• BS degree in life sciences, a health related field, or equivalent combination of education and experience.
• Extensive 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.
• Excellent 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.
• Above-average attention to detail, effective oral/written communication skills along with the ability to work independently to meet deadlines.
• Excellent leadership skills; ability to teach/mentor team members. Ability to coach employees to reach performance objectives.
• Strong background in issue resolution, meeting customer deliverables and driving best practices at organization or customer portfolio level.

AtSyneos 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: $79,800.00 - $139,600.00 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. 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.

Discover what our Syneos Health colleagues already know: work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients. We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you'll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing. The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role. Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients’ lives around the world.

Selecting us as an employer secures a career in which you’re guaranteed to: Partner with the most diverse team of experts in the industry. From the top down, our people are inspiring. Everyone has a voice and is encouraged to use it. Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration. We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population. We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.