Job Title:
Clinical System Designer II
Job Reference: JR128818
Locations: Bangalore, Chennai, Trivandrum, Bengaluru
Department: Clinical Systems
Work Arrangement: Hybrid (Office-Based)
Hiring Manager: Amrutha Saidala
About ICON plc
ICON plc is a leading healthcare intelligence and clinical research organization, committed to fostering an inclusive environment that drives innovation and excellence in clinical development. Join us as we shape the future of clinical research.
Role Summary
As a Clinical System Designer II, you will be responsible for designing clinical data management system (CDMS) components, ensuring quality and compliance with study protocols, and supporting study build activities for clinical trials across multiple locations.
Key Responsibilities
Functional Knowledge
Demonstrate excellent functional knowledge of CRF design tools and proficiency in at least one clinical data management system (CDMS), with basic understanding of a second system.
Design CDMS components based on medium complexity clinical trial protocols.
Copy, modify, and maintain Case Report Forms (CRFs) from standard libraries and other studies.
Develop custom CRF screens, edit checks, and dynamic check specifications.
Perform quality control peer reviews of database specifications.
Lead eCRF and specification review meetings.
Create and maintain standard libraries for study components.
Customize edit checks to meet trial-specific requirements.
Assist with programming dynamic checks and discrepancy edit checks.
Obtain approvals for release of system components to production.
Support impact assessments and change management for post-production database changes.
Business Expertise
Act as the primary contact for design-related questions during study build.
Ensure adherence to study protocols, contracts, and scope of work.
Track and report any issues affecting timelines, scope, or budget; escalate as needed.
Prepare high-level system requirements documents and manage their review.
Support bid defense materials and client demonstrations.
Maintain meeting minutes, issue logs, and escalation documentation.
Participate in study kickoff meetings (internal and external).
Support Clinical Systems Lead (CSL) with negotiation and decision-making.
Leadership
Assist and mentor junior Clinical System Designers.
Assess and address training needs within the team.
Organize and deliver training and refresher sessions.
Review progress of delegated activities.
Promote process improvements focusing on business and client value.
Travel domestically and internationally (~10%).
Problem Solving
Analyze and resolve problems related to clinical system design.
Assist with improvements to Clinical System Designer systems and processes.
Impact & Interpersonal Skills
Contribute to achievement of short- and medium-term goals.
Exhibit strong written, oral communication, and presentation skills.
Foster effective communication across teams.
Qualifications & Experience
Typically requires 3+ years of relevant experience.
Equivalent combination of education, training, and experience considered.
Strong understanding of clinical data management systems and CRF design.
What ICON Can Offer You
Competitive salary and comprehensive benefits package.
Various annual leave entitlements.
Health insurance options tailored for you and your family.
Competitive retirement planning offerings.
Global Employee Assistance Programme (LifeWorks) with 24/7 access.
Life assurance.
Flexible, country-specific benefits (childcare vouchers, bike schemes, gym discounts, subsidized travel, health assessments).
A culture of diversity, inclusion, and belonging.
Inclusion & Accessibility
ICON is committed to an inclusive, discrimination-free workplace. We provide reasonable accommodations for applicants with medical conditions or disabilities. All qualified candidates will receive equal consideration regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Application Notes
Encouraged to apply even if you don’t meet all listed criteria.
Current ICON employees should apply via the internal portal.
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