via Workday
$Not specified
Lead country-level clinical study operations from start-up through closeout ensuring compliance and performance.
Requires deep clinical trial management experience, knowledge of ICH/GCP, regulatory submissions, and cross-functional leadership.
Country Operations Manager (cSOM)/ CTM (Sponsor dedicated/ Remote - US) 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 Country Operations Manager (cSOM) Sponsor-Dedicated | Country-Level Clinical Study Leadership | Exceptional Team Environment We are seeking an experienced Country Operations Manager (cSOM) to join our Sponsor-Dedicated clinical operations team. This is a high-visibility role embedded within a leading global sponsor environment, where you will serve as the country-level operational leader driving execution from study start-up through closeout. You will join an established, collaborative, and high-performing team known for operational excellence, strong partnership, and a culture of support and accountability. Position Overview As the primary member of the Operational Sub-Team and leader of the Regional/Country Operational Sub-Team, the cSOM serves as the country “lens” of the study—ensuring global strategy is executed seamlessly at the local level. You will be accountable for: Country-level deliverables within the overall study plan Performance oversight using study metrics and progress updates Risk identification and mitigation Recruitment acceleration and data quality performance Vendor management at the local level Ensuring compliance with ICH/GCP, SOPs, and local regulatory requirements This role blends elements of Study Manager, CTM, and CRO-facing operational leadership—providing meaningful ownership and end-to-end accountability at the country level. What You’ll Do 🔹 Country-Level Operational Leadership Develop and maintain accurate country-level operational plans Oversee execution of milestones from start-up through closeout Ensure inspection readiness at country and site level Lead the Regional/Country Operational Sub-Team 🔹 Study Start-Up & Activation Coordinate IRB/IEC and regulatory submission strategies Manage country-level translation and Informed Consent Document (ICD) development Review PTAs and SIV documentation Conduct country kick-off meetings Oversee milestone tracking and start-up deliverables 🔹 Recruitment & Data Excellence Drive recruitment performance at the regional/country level Review study metrics and implement performance improvement actions Lead country-level data cleaning activities during maintenance and database lock Ensure protocol deviation follow-up and compliance monitoring 🔹 Vendor & Stakeholder Management Provide oversight of local vendors Review Site Care Partner reports and issue documentation Ensure seamless bidirectional communication between global and local teams Partner closely with the Global Study Manager (GSM), Study Operations Manager (sSOM), Site Care Partners, Regulatory, Medical Affairs, and Contracts teams 🔹 Risk & Issue Management Identify and mitigate country-level operational risks Ensure timely issue resolution Maintain alignment with global timelines and deliverables 🔹 Closeout Leadership Oversee site closure documentation and review Support end-of-trial notifications Ensure vendor closeout and supply reconciliation What We’re Looking For: Strong clinical trial management (CTM) experience at country or regional level Demonstrated expertise across start-up, conduct, and closeout Deep knowledge of ICH/GCP and local regulatory requirements Experience driving recruitment and data quality performance Vendor oversight and cross-functional stakeholder leadership experience Strong analytical, organizational, and communication skills Why Join This Sponsor-Dedicated Team: Embedded within a global sponsor organization Direct exposure to sponsor decision-making and strategy High-performing, collaborative, and supportive team culture Meaningful ownership and visibility Opportunity to influence recruitment, quality, and study timelines directly This is an opportunity to step into a strategic, high-impact country leadership role within a sponsor-dedicated environment that values accountability, partnership, and operational excellence. If you are ready to bring your country-level expertise to a team that truly operates as one, we would love to connect. 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. 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.
This job posting was last updated on 2/25/2026