RTSM/eCOA Manager ( Sponsor-Dedicated/ Remote- US only)

About this role

RTSM/eCOA Manager ( Sponsor-Dedicated/ Remote- US only) 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

RTSM/eCOA Manager Location: Remote (U.S.)   Overview

We are seeking an experienced RTSM/eCOA Manager to join a sponsor-dedicated clinical development team supporting a diverse portfolio of clinical trials. This fully remote role will provide end-to-end leadership for Randomization and Trial Supply Management (RTSM/IRT) and eCOA systems, serving as the primary subject matter expert and operational lead across study teams, Clinical Operations, and external vendors.

The successful candidate will bring deep RTSM/IRT expertise, hands-on system build experience, strong User Acceptance Testing (UAT) leadership, and a passion for driving quality, compliance, and continuous improvement in a regulated clinical research environment.

Key Responsibilities

RTSM/IRT/eCOA Management • Lead the design, development, configuration, implementation, and lifecycle management of RTSM/IRT and eCOA systems. • Partner with Clinical Operations and cross-functional study teams to gather requirements and ensure alignment on scope, timelines, and deliverables. • Serve as the primary RTSM subject matter expert throughout the study lifecycle. • Develop and maintain User Requirement Specifications (URS), system design documentation, and related study documentation. • Oversee vendor deliverables and ensure quality, accuracy, and timely execution.

Testing, Validation & Compliance • Lead User Acceptance Testing (UAT) activities, including test strategy, script execution, defect management, and documentation review. • Ensure completion, review, approval, and filing of validation and testing documentation in accordance with quality standards. • Investigate and resolve system issues, defects, and deviations in partnership with vendors and internal stakeholders. • Manage change controls and emergency system updates. • Ensure RTSM systems, processes, and documentation comply with SOPs, GxP requirements, and applicable regulations. • Support inspection readiness and audit preparedness activities.

Vendor & Stakeholder Management • Act as the primary liaison between study teams, RTSM/eCOA vendors, and internal functional groups. • Manage vendor relationships, performance, timelines, risks, and issue escalation. • Facilitate communication and alignment across Clinical Operations, Quality, Data Management, and other stakeholders.

Process Improvement & Training • Develop and implement standardized RTSM processes and best practices. • Document end-to-end workflows and associated procedural guidance. • Identify process gaps and drive continuous improvement initiatives. • Manage RTSM user access requests, modifications, removals, and periodic access reviews. • Develop role-based RTSM training curricula and materials. • Ensure training programs align with system functionality, operational processes, and regulatory expectations.

Required Qualifications • Bachelor's degree (BA/BS) required. • Minimum of 5 years of clinical trial operations experience within a pharmaceutical, biotechnology, or CRO environment. • Minimum of 2-3 years of direct RTSM/IRT experience, including management of system builds and study updates. • Strong knowledge of RTSM/IRT (IVRS/IWRS) and eCOA platforms. • Proven experience leading User Acceptance Testing (UAT) and validation activities. • Hands-on experience working with RTSM/IRT/eCOA vendors and managing vendor deliverables. • Project management experience supporting complex, cross-functional clinical studies or programs. • Experience with testing, validation, and issue-tracking tools. • Strong problem-solving and root-cause analysis skills. • Excellent communication, stakeholder management, negotiation, and organizational abilities. • Ability to work independently in a fast-paced, matrixed environment.

Preferred Qualifications • Experience operating at a Project Manager II level within a CRO or sponsor organization (e.g., Syneos PM II equivalent). • Experience supporting multiple global studies simultaneously. • Knowledge of FDA, ICH-GCP, and GxP regulations.

Why Join Us? • Fully remote opportunity. • Dedicated support of a leading sponsor organization. • High visibility role with cross-functional collaboration. • Opportunit

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