Clinical System Designer II – ICON plc
Locations: Bangalore / Chennai / Trivandrum / Bengaluru
Job ID: JR128818
Portfolio: Full Service & Corporate Support – Clinical Systems
Work Type: Hybrid / Office-Based
Company Overview
ICON plc is a world-leading healthcare intelligence and clinical research organization. We foster an inclusive environment that drives innovation and excellence, advancing the future of clinical development.
Role Overview
The Clinical System Designer II (CSD II) is responsible for designing, building, and maintaining clinical database systems and components. This includes CRF design, edit check development, quality control, and supporting study teams through system setup and ongoing maintenance. The role also involves mentoring junior staff, ensuring process improvement, and contributing to clinical system design standards.
Key Responsibilities
Functional Knowledge:
Expertise in CRF design tools and at least one clinical data management system (CDMS), with basic understanding of a second CDMS.
Plan and design CDMS components based on medium complexity clinical trial protocols.
Serve as primary point of contact for design-related questions during study build.
Read and adhere to study protocols, contracts, and scope of work during study setup, maintenance, and close-out.
Business Expertise:
Track and report issues affecting project timelines, scope, or budget; escalate effectively.
Consolidate high-level system requirements documents and manage reviews.
Copy and modify CRFs from standard libraries; support library item reuse.
Develop Custom CRF screens, Edit Check, and Dynamic Check specifications using prototyping methods.
Perform quality control peer reviews of database-related specifications.
Lead eCRF and specification review meetings.
Maintain and utilize standard libraries and adapt edit checks to trial-specific requirements.
Support bid defense materials, client demos, and industry meetings as required.
Obtain approvals for system component release to live/production environments.
Track meeting minutes, issue logs, and escalate appropriately.
Assess impact of post-production changes and maintain change management documentation.
Leadership:
Mentor and assist team members; provide refresher training to junior CSD staff.
Review delegated team activities and progress.
Organize and administer training programs for junior staff.
Promote a culture of process improvement, streamlining processes and adding value to client needs.
Travel domestically or internationally (~10%).
Problem Solving & Impact:
Identify and analyze problems; solutions may not be readily apparent.
Develop and implement improvements to CSD systems and processes.
Contribute to short- to medium-term project goals through personal effort and influence.
Interpersonal Skills:
Strong written, oral, and presentation skills.
Effective communication across teams and functions.
Experience Requirement:
Minimum 3+ years relevant experience; equivalent education, training, and experience may be considered.
Benefits
ICON offers competitive compensation along with benefits focused on well-being and work-life balance, including:
Annual leave entitlements
Health insurance options for employees and families
Competitive retirement planning offerings
Global Employee Assistance Programme (LifeWorks, 24/7 access to specialized professionals)
Life assurance
Flexible, country-specific optional benefits (childcare vouchers, bike purchase schemes, gym memberships, subsidized travel passes, health assessments, etc.)
More details: ICON Careers Benefits
Diversity & Inclusion
ICON values inclusion and belonging. All candidates receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Reasonable accommodations are available: Request here
Application Encouragement
Even if you don’t meet all requirements, you are encouraged to apply – you may be exactly what ICON is looking for.
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