eCOA Project Manager

eCOA Project Manager

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

eCOA Project Manager

Sponsor-Dedicated | Remote (U.S. & Canada)

Are you an RTSM expert who thrives in complex clinical environments and enjoys owning the operational execution behind critical trial systems?

This is a highly visible opportunity supporting a diverse portfolio of clinical trials where RTSM, IRT, and eCOA systems play a critical role in study execution. The ideal candidate is someone who combines deep technical expertise with strong project management capabilities and enjoys partnering cross-functionally to deliver high-quality solutions throughout the entire study lifecycle.

You won't simply oversee vendors from a distance—you'll serve as the operational lead and subject matter expert, ensuring that systems are designed, tested, implemented, and maintained to the highest standards of quality and compliance.

If you enjoy solving complex problems, driving continuous improvement, and collaborating across functions to support successful clinical trials, this could be an excellent next step in your career.

WHY THIS OPPORTUNITY

• High-impact role supporting multiple studies across a diverse clinical portfolio.
• Opportunity to serve as the RTSM/eCOA Subject Matter Expert within a sponsor-dedicated environment.
• Significant ownership and visibility across Clinical Operations and cross-functional teams.
• Strong partnership with vendors and internal stakeholders.
• Fast-paced environment where innovation and problem-solving are valued.
• Opportunity to influence and standardize RTSM processes and best practices.
• Collaborative culture focused on quality, accountability, and continuous improvement.

WHAT YOU WILL OWN

End-to-End RTSM/eCOA Leadership

• Lead the design, development, configuration, and lifecycle management of RTSM/IRT/eCOA systems.
• Partner closely with Clinical Operations and study teams to understand protocol requirements and ensure alignment on timelines, scope, and deliverables.
• Develop and maintain User Requirement Specifications (URS) and system design documentation.
• Serve as the primary operational point of contact for RTSM activities across assigned studies.
• Provide ongoing RTSM/eCOA expertise throughout the entire study lifecycle.

System Delivery, Testing & Validation

• Lead User Acceptance Testing (UAT) activities and validation efforts.
• Ensure completion, review, and filing of testing and validation documentation.
• Oversee quality reviews and approval of validation documentation.
• Collaborate with vendors and study teams to identify, investigate, and resolve system issues.
• Manage emergency changes and change control activities.

Vendor & Stakeholder Management

• Act as the liaison between Clinical Operations, RTSM/eCOA vendors, and internal stakeholders.
• Drive accountability for vendor deliverables and timelines.
• Facilitate effective communication across matrixed teams.
• Support issue escalation and resolution activities.

Process Excellence & Inspection Readiness

• Ensure RTSM processes align with SOPs, regulatory requirements, and quality standards.
• Support inspection readiness initiatives.
• Identify process gaps and implement continuous improvement opportunities.
• Develop standardized RTSM workflows and supporting guidance documents.
• Ensure consistent execution across studies.

User Access & Training Oversight

• Manage RTSM user access requests, modifications, and removals.
• Oversee periodic access reviews and audit readiness activities.
• Develop and maintain role-based RTSM training materials.
• Ensure training aligns with system functionality and regulatory expectations.

WHAT YOU BRING

Required Experience

• Bachelor's degree required (BA/BS).
• Minimum of 5 years of operational experience within clinical trials in a pharmaceutical company and/or CRO environment.
• Deep expertise in RTSM/IRT (IVRS/IWRS) systems and working knowledge of eCOA platforms .
• End-to-end experience managing RTSM system builds, updates, and implementations.
• Proven experience leading User Acceptance Testing (UAT) and validation activities.
• Hands-on experience working directly with RTSM/eCOA vendors.
• Vendor management experience within clinical research environments.
• Project management experience supporting complex, matrixed studies or programs.

Technical & Regulatory Expertise

• Strong understanding of the end-to-end clinical trial process.
• Familiarity with testing and issue-tracking tools.
• Knowledge of GCP principles and applicable regulatory requirements.
• Experience supporting inspection readiness activities.
• Understanding of SOP compliance and system security controls.

Key Strengths

• Strong analytical and problem-solving capabilities.
• Ability to independently identify issues, determine root causes, and implement solutions.
• Excellent communication and stakeholder management skills.
• Strong organization and prioritization abilities.
• Ability to influence cross-functional teams in a matrix environment.
• Continuous improvement mindset with a proactive approach to operational excellence.

LOCATION

This opportunity is open to candidates located in:

• United States
• Canada

Remote/home-based candidates are welcome to apply.

TEAM CULTURE

This team values collaboration, ownership, and operational excellence. Success in this role requires someone who enjoys being hands-on, working through complexity, and building strong partnerships across functions and vendors. Leadership is supportive and highly collaborative, while maintaining high expectations around accountability, quality, and delivery.

If you're looking for an opportunity where you can leverage your RTSM expertise, expand your impact across multiple studies, and play a critical role in driving successful clinical trial execution, we'd love to hear from you.

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:

$114,000.00 - $210,900.00

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.

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.

Summary

Job Summary The RTSM/eCOA Manager is responsible for end-to-end leadership of Randomization and Trial Supply Management (RTSM/IRT) systems and eCOA in collaboration with Clinical Operations across a diverse clinical trial portfolio. This role serves as the subject matter expert (SME) and primary point of contact for RTSM activities, working closely with Clinical Operations, vendors, and cross functional study teams to ensure high-quality system design, delivery, testing, and ongoing support. The incumbent leads RTSM system development and User Acceptance Testing (UAT), oversees vendor deliveries, manages timelines and risks, and ensures compliance with regulatory and quality standards. This role requires strong technical expertise, project management skills, and a continuous improvement mindset to maintain RTSM processes at industry best practice levels.