Country Operations Manager; cSOM​/CTM; Sponsor dedicated​/Remote

Country Operations Manager (cSOM)/ CTM (Sponsor dedicated/ Remote - US)

Updated: Yesterday
Location: Morrisville, NC, United States
Job :

Description

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

• 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…