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

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.

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.

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

• 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.