RSTM/eCOA Manager
As a RTSM/eCOA Manager, you will be 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 cross0functional study teams to ensure high-quality system design, delivery, testing, and ongoing support.
What You Will Do:
You will manage day-to-day scientific operations activities, supporting your team to deliver quality outcomes.
Key responsibilities include:
- Support design, development, configuration, and lifecycle management of RTSM/IRT/eCOA systems to meet protocol and study requirements.
- Partner with Clinical Operations and study teams to understand RTSM/IRT/eCOA requirements and ensure alignment on scope, timelines, and deliverables.
- Develop and manage User Requirement Specifications (URS) and system design documentation.
- Ensure completion, review, and filing of validation and testing documentation in accordance with quality standards.
- Provide ongoing RTSM/IRT subject matter expertise to cross0functional study teams throughout the study lifecycle.
- Identify, investigate, and resolve system defects and issues in collaboration with Quality, Clinical Operations, and vendors on deviations.
- Manage change control and emergency system changes.
- Serve as the primary operational interface between study teams, RTSM vendors, and internal functional teams.
- Ensure RTSM systems and documentation comply with SOPs and applicable regulations.
- Oversee quality reviews, validation documentation approval.
- Managing RTSM user access requests, modifications, and removals, including oversight of periodic access reviews and audit readiness.
- Alignment with SOPs, regulatory expectations, and system security controls.
- Support the development and implement standardized RTSM processes.
- Document end0to0end RTSM workflows and associated guidance.
- Identify process gaps and drive continuous improvement aligned with SOPs and regulations.
- Ensure RTSM processes support inspection readiness and consistent execution.
- Develop role0based RTSM training curricula and materials.
- Ensure training aligns with processes, system functionality, and regulatory expectations.
Your Profile:
- Bachelor0s degree required (BA/BS).
- Minimum 5 years of operational experience in clinical trials within a pharmaceutical company and/or CRO.
- Strong knowledge of the clinical trial process, with deep expertise in RTSM/IRT (IVRS/IWRS) eCOA systems.
- End0to0end experience managing RTSM system builds and updates.
- Proven experience leading User Acceptance Testing (UAT) and validation activities.
- Hands0on experience working with RTSM/IRT/eCOA vendors; vendor management experience required.
- Project management experience managing complex, matrixed studies or programs.
- Familiarity with testing and issue0tracking tools.
- Ability to independently identify issues, analyze root causes, and implement solutions in a complex environment.
- Strong communication, negotiation, and stakeholder0management skills.
- Demonstrated leadership, organization, and prioritization capabilities.
What ICON can offer you:
Our success depends on the quality of our people. That0s why we0ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family0s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family0s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Visit our to read more about the benefits ICON offers.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless 0 there0s every chance you0re exactly what we0re looking for here at ICON whether it is for this or other roles.
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