Responsibilities
Designs and configures electronic case report forms (eCRFs), (e.g., metadata, eCRF library, data checks, derivations, skip logic, rules, alerts, calculations); consults with teams as expert in eCRF layout and clinical database design and has expertise in requirements writing; serves as department subject matter expert in design and configuration.
Provides expertise in configuration of complex protocols, visit schedules/folders and sites in relevant clinical data system builder or architect module and advises on best approaches and implementation.
Provides expertise in complex system/database build features both within EDC and any additional modules (e.g., ePRO, specimen tracking, randomization) as applicable to clinical data system; advises team to ensure streamlined system configuration and appropriate capability.
Provides expertise in evaluating complex requirements, determines feasibility based on system capabilities, identifies and implements novel or unique solutions
Performs complex eCRF and data system quality control, testing and verification activities with high degree of accuracy and consistency; may provide consultation to other teams within department
Writes and executes test scripts for complex configurations.
Performs EDC releases (Test, Train and Production), depending on the EDC system; including CRO global library.
Implements/programs Data Validation Plans/Specifications; programs SQL based or configuration based data validation checks. Creates custom functions and procedures; reviews or performs manual data changes; may perform code review.
Provides expertise for implementation of CDISC standards such as CDASH and SDTM within the EDC system; may perform SDTM mapping using SQL or other language; supports development and maintenance of global standards within therapeutic area.
Implements complex Data Migration Plans (e.g., study data import/export, clone or transfer of previous study); configures or develops complex data integration, upload, or transfer.
Ensure compliance with industry quality standards, regulations, guidelines and procedures including applicable Federal Regulations and ICH/GCP.
Utilizes tracking system to document configuration and testing activities, maintain version control on all required configuration specifications, validation, and quality control documents as required by SOP; may contribute to review of department SOPs or work practices.
May administer system modules (e.g., reports, PDF services, batch uploader) or perform user or site administration across applications.
May serve as a Product Owner, Scrum Master, or Tester on the Agile team; participates in Agile cross team coordination meetings to facilitate sharing of ideas and process improvements across teams.
Provides mentorship of senior team members and demonstrates technical leadership within a clinical data system or therapeutic area; participates in initiatives or committees relevant to system delivery team processes.
Provides technical support to internal users for complex issues; reports defects and follows through to resolution ensures proper escalation and notification to other impacted teams; may participate in review of system issue trends and corrective actions.
Performs other duties as assigned
Complies with all policies and standards
Qualifications
Bachelor's Degree Analytic, technical, programming, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree. Required
7-9 years of progressive clinical database development experience (or master's degree with 6 years) and strong understanding of clinical research and clinical database development and Agile processes Required
4-6 years Experience with database structures and programming languages Preferred
4-6 years Experience with eCRF design and specifications development Preferred
4-6 years Experience writing, programming, or configuring data validation checks Preferred
4-6 years Experience with QC, UAT, platform testing, and writing and executing test scripts Preferred
4-6 years Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, and CDISC standards (CDASH, SDTM) Preferred
4-6 years Knowledge of software development lifecycle activities; experience with Agile/Scrum Preferred
Expertise in eCRF design, clinical database configuration, and system architecture. High
Strong proficiency in SQL, programming, and implementation of data validation checks. High
Deep understanding of CDISC standard, DASH, SDTM, and clinical research methodology. High
Experience with Agile and Scrum processes and ability to serve as Product Owner or Scrum Master. High
Strong analytical, problem solving, and technical troubleshooting skills. High
Ability to mentor and provide technical leadership to team members. High
Excellent communication and collaboration skills to work with cross functional teams. High
If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.
CONNECT WITH US!
Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/
Designs and configures electronic case report forms (eCRFs), (e.g., metadata, eCRF library, data checks, derivations, skip logic, rules, alerts, calculations); consults with teams as expert in eCRF layout and clinical database design and has expertise in requirements writing; serves as department subject matter expert in design and configuration.
Provides expertise in configuration of complex protocols, visit schedules/folders and sites in relevant clinical data system builder or architect module and advises on best approaches and implementation.
Provides expertise in complex system/database build features both within EDC and any additional modules (e.g., ePRO, specimen tracking, randomization) as applicable to clinical data system; advises team to ensure streamlined system configuration and appropriate capability.
Provides expertise in evaluating complex requirements, determines feasibility based on system capabilities, identifies and implements novel or unique solutions
Performs complex eCRF and data system quality control, testing and verification activities with high degree of accuracy and consistency; may provide consultation to other teams within department
Writes and executes test scripts for complex configurations.
Performs EDC releases (Test, Train and Production), depending on the EDC system; including CRO global library.
Implements/programs Data Validation Plans/Specifications; programs SQL based or configuration based data validation checks. Creates custom functions and procedures; reviews or performs manual data changes; may perform code review.
Provides expertise for implementation of CDISC standards such as CDASH and SDTM within the EDC system; may perform SDTM mapping using SQL or other language; supports development and maintenance of global standards within therapeutic area.
Implements complex Data Migration Plans (e.g., study data import/export, clone or transfer of previous study); configures or develops complex data integration, upload, or transfer.
Ensure compliance with industry quality standards, regulations, guidelines and procedures including applicable Federal Regulations and ICH/GCP.
Utilizes tracking system to document configuration and testing activities, maintain version control on all required configuration specifications, validation, and quality control documents as required by SOP; may contribute to review of department SOPs or work practices.
May administer system modules (e.g., reports, PDF services, batch uploader) or perform user or site administration across applications.
May serve as a Product Owner, Scrum Master, or Tester on the Agile team; participates in Agile cross team coordination meetings to facilitate sharing of ideas and process improvements across teams.
Provides mentorship of senior team members and demonstrates technical leadership within a clinical data system or therapeutic area; participates in initiatives or committees relevant to system delivery team processes.
Provides technical support to internal users for complex issues; reports defects and follows through to resolution ensures proper escalation and notification to other impacted teams; may participate in review of system issue trends and corrective actions.
Performs other duties as assigned
Complies with all policies and standards
Bachelor's Degree Analytic, technical, programming, or related discipline; equivalent combination of education and relevant work experience may be considered in lieu of a degree. Required
7-9 years of progressive clinical database development experience (or master's degree with 6 years) and strong understanding of clinical research and clinical database development and Agile processes Required
4-6 years Experience with database structures and programming languages Preferred
4-6 years Experience with eCRF design and specifications development Preferred
4-6 years Experience writing, programming, or configuring data validation checks Preferred
4-6 years Experience with QC, UAT, platform testing, and writing and executing test scripts Preferred
4-6 years Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, and CDISC standards (CDASH, SDTM) Preferred
4-6 years Knowledge of software development lifecycle activities; experience with Agile/Scrum Preferred
Expertise in eCRF design, clinical database configuration, and system architecture. High
Strong proficiency in SQL, programming, and implementation of data validation checks. High
Deep understanding of CDISC standard, DASH, SDTM, and clinical research methodology. High
Experience with Agile and Scrum processes and ability to serve as Product Owner or Scrum Master. High
Strong analytical, problem solving, and technical troubleshooting skills. High
Ability to mentor and provide technical leadership to team members. High
Excellent communication and collaboration skills to work with cross functional teams. High
If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.
CONNECT WITH US!
Find us on LinkedIn:/the-emmes-group/
Visit our website:https://www.theemmesgroup.com/
