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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in designing and delivering clinical systems, ensuring compliance with regulations and standards while optimizing system functionality and user experience. Proven ability to lead cross-functional collaboration and mentor team members in clinical technology.
Highest-signal resume keywords
Clinical Technology ExperienceEDC System DesignIRT System IntegrationKnowledge of GCPs and ICH GuidelinesProject Management Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Systems DesignSystem IntegrationData Standards ApplicationCommon Industry Design ToolsClinical Trial Process UnderstandingCDASH KnowledgeSDTM Knowledge
Soft Skills
Effective CommunicationAnalytical SkillsInfluencing Without AuthorityCoaching and Mentoring
Tools & Technologies
Project Management Tools
Industry Keywords
GCPsICH GuidelinesSOPsClinical DevelopmentData Flow Optimization
About the role
Key responsibilities & impact- Design and deliver new clinical systems, system integrations, and required changes to clinical systems including EDC and IRT
- Use project management tools to track study progress and plan work
- Identify issues affecting timelines or quality and develop solutions
- Ensure study protocol requirements are reflected in system designs
- Apply common data standards and optimize system functionality, end-user experience, and data flow
- Ensure therapeutic-area and program-level consistency
- Collaborate with DSS and cross-functional team members to achieve program and study objectives
- Synchronize work products with upstream and downstream dependencies
- Ensure adherence to regulations, GCPs, ICH Guidelines, SOPs, and functional quality standards
- Monitor evolving regulations, guidelines, and policies related to clinical development
- Coach and mentor Data Science Associates
- Participate in innovation and process improvement initiatives
Requirements
What you’ll need- Bachelor’s degree in business, management information systems, computer science, life sciences, or equivalent
- Master’s degree preferred
- 3+ years of clinical technology experience (e.g., EDC, IRT, ePRO), or 5+ years of experience in a similar technical role or clinical development role
- Experience with common industry design and development tools preferred
- Demonstrated understanding of the clinical trial process
- Knowledge of CDASH and SDTM
- Ability to influence others without direct authority
- Effective communication skills
- Effective analytical skills
- Knowledge of federal and applicable local regulations, GCPs, ICH Guidelines, and SOPs
Benefits
Comp & perks- Paid time off, including vacation, holidays, and sick leave
- Medical, dental, and vision insurance
- 401(k)
- Short-term incentive programs
- Remote work eligibility
- Equal opportunity employer benefits and reasonable accommodation support
