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Study Configuration Analyst
Syneos Health. Configure studies based on final protocols and operational needs .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Data Management processes, including configuration of studies based on clinical protocols and compliance with CDISC standards. Proficient in creating and modifying patient-file templates and facilitating user training to enhance operational efficiency.
Highest-signal resume keywords
Clinical Data ManagementCDISC StandardsStudy ConfigurationClinspark ExperienceClinical Programming
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Study ConfigurationClinical Data ManagementCDISC StandardsSDTMCDASHClinical ProgrammingData IntegrationWorkflow ManagementUser TrainingReport Creation
Soft Skills
User Feedback IntegrationCoaching
Tools & Technologies
ClinsparkRaveVeeva
Industry Keywords
Phase I Clinical StudiesProtocol-Driven Study SetupStandard Operating ProceduresOperating Guidelines
About the role
Key responsibilities & impact- Configure studies based on final protocols and operational needs
- Assist IT with developing, testing, evaluating, and implementing new technologies
- Assist users with study and system configuration
- Conduct user training and coaching
- Improve existing configurations based on user feedback and harmonize configuration practices with team members
- Create reports, input screens, and documents to facilitate task execution
- Update configurations to satisfy specific data collection requests from internal and external clients
- Create and modify patient-file templates based on user consultation and feedback
- Ensure contingency-plan documents meet requirements
- Perform other clinical tasks as assigned
Requirements
What you’ll need- Strong understanding of Clinical Data Management processes
- Knowledge of CDISC standards, SDTM, and CDASH
- Strong DM/CDISC/Rave/Veeva profiles can be considered without extensive Clinspark experience
- Ability to understand and configure studies based on clinical protocols
- Experience working with clinical study data integration and workflows
- Familiarity with Phase I clinical studies and protocol-driven study setup
- Preferred: 2-3 years of Clinspark experience
- Clinical Programming experience is valuable if combined with study configuration and EDC knowledge
- Activities must comply with applicable Corporate and Divisional Policies, Standard Operating Procedures, and Operating Guidelines
Benefits
Comp & perks- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture