Clinical Trial Manager II - Study Manager (RWE, contract negotiation)
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
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 accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
WORK HERE MATTERS EVERYWHERE
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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
- We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
Job Responsibilities
Role Responsibilities
- Lead operational delivery of multiple Real World Evidence (RWE) and clinical studies (typically 10–12 studies), ensuring high‑quality and timely execution across global regions.
- Apply global operational expertise to support feasibility, site engagement, and study startup activities.
- Utilize prior CRA experience (asset) to guide monitoring strategy, assess site performance, and identify operational risks early.
- Act as a key facilitator for external research collaborations, serving as the primary contact for vendor and partner engagement.
- Manage contract processes by collecting operational requirements, identifying red flags, understanding stakeholder needs, and ensuring smooth contract negotiation and execution.
- Lead budget development and oversight, including FMV analysis, cost metrics, and milestone creation, ensuring accurate forecasting and proactive financial management.
- Oversee vendor performance and relationship management, ensuring alignment on deliverables, timelines, data flow, and study quality.
- Maintain oversight of operational risks and mitigation strategies across all assigned studies, escalating issues as needed.
- Collaborate effectively within cross‑functional teams (clinical, data management, regulatory, medical, procurement, etc.) to ensure operational alignment and problem resolution.
- Apply strong project management skills to prioritize workload, manage timelines, track progress, and ensure adherence to study plans.
- Utilize strategic thinking and analytical skills to interpret study data, anticipate challenges, and drive continuous improvement in study processes.
- Communicate proactively and clearly with internal stakeholders, external partners, and study teams, ensuring transparency and alignment on expectations and timelines.
- Contribute to inspection readiness and quality compliance across studies, supporting audits and regulatory activities as required.
Qualifications:
- Experience in Real‑World Evidence (RWE) preferred.
- Background in clinical trial or study management with solid knowledge of GCP, monitoring, and clinical/regulatory operations.
- BS/Nursing with 2+ years of relevant experience, or MS/PhD with 1+ year.
- Proven experience overseeing CROs, external partners, and vendors.
- Strong contract negotiation and contract facilitation experience (gathering requirements, identifying red flags, supporting negotiation flow).
- Skilled in budget management, including FMV assessment, cost projections, and milestone planning.
- Ability to interpret study‑level data, identify operational risks, and proactively mitigate issues.
- Understanding of protocol feasibility and operational implementation challenges.
- Excellent communication and interpersonal skills, with cross‑cultural awareness; English fluency required.
- Highly organized, detail‑oriented, and proficient with technical tools (spreadsheets, metrics, data flow systems).
- Strong analytical, problem‑solving, and cross‑functional collaboration skills.
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.
