The Fountain Groups · 15 hours ago
Clinical Medidata Rave Systems Designer / Analyst II
United States
Contract
Remote
Mid, Senior Level
$37/hr - $42/hr
3+ years expThe Fountain Groups is a company focused on clinical technology solutions, and they are seeking a Clinical Medidata Rave Systems Designer / Analyst II. This role is essential for ensuring the successful design and delivery of Electronic Data Capture (EDC) systems for clinical trials, while adhering to regulatory standards and optimizing data flow.
Staffing & Recruiting
Hiring Manager
Maureen Fanning
Responsibilities
Ensures that the requirements of each study protocol are reflected in the Electronic Data Captures (EDC) design and that common data standards are used
Ensures that EDC is specified to optimize on functionality, end user experience, and data flow
Accountable for the on-time design and delivery of new EDC systems, integrations between EDC and other applicable systems (e.g. IRT)., as well as any required changes to EDC. Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
Ensures that TA- and program-level consistency is achieved
Interacts with and influences DSS and cross-functional team members to achieve program and study objectives. Ensures that assigned work product is synchronized with upstream and downstream dependencies
Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), and to functional quality standards. Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
Utilizes project management tools to track study progress and plan work. Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
Participates in DSS and cross-functional innovation and process improvement initiatives
Experience with common industry design and development tools preferred
Demonstrated understanding of clinical trial process
Knowledge of CDASH and SDTM
Demonstrated ability to influence of others without direct authority
Demonstrated effective communication skills
Demonstrated effective analytical skills
Qualification
Required
Bachelor's degree in business, management information systems, computer science, life sciences or equivalent
Must have 3+ years of clinical technology experience (EDC) or 5+ years of experience in a similar technical role or in a clinical development role
1. Medidata Rave Certification w/ 3+ years of study building
Ability to design and delivery of new EDC systems, integrations between EDC and other applicable systems (e.g. IRT), as well as any required changes to EDC
Ensures that the requirements of each study protocol are reflected in the Electronic Data Captures (EDC) design and that common data standards are used
Ensures that EDC is specified to optimize on functionality, end user experience, and data flow
Accountable for the on-time design and delivery of new EDC systems, integrations between EDC and other applicable systems (e.g. IRT), as well as any required changes to EDC
Utilizes project management tools to track study progress and plan work
Anticipates and identifies issues that could affect timelines or quality and develops options and solutions
Ensures that TA- and program-level consistency is achieved
Interacts with and influences DSS and cross-functional team members to achieve program and study objectives
Ensures that assigned work product is synchronized with upstream and downstream dependencies
Ensures adherence to federal regulations and applicable local regulations, Good Clinical Practices (GCPs), ICH Guidelines, Standard Operating Procedures (SOPs), and to functional quality standards
Stays abreast of new and/or evolving local regulations, guidelines and policies related to clinical development
Participates in DSS and cross-functional innovation and process improvement initiatives
Demonstrated understanding of clinical trial process
Knowledge of CDASH and SDTM
Demonstrated ability to influence of others without direct authority
Demonstrated effective communication skills
Demonstrated effective analytical skills
Preferred
Masters preferred
Experience with common industry design and development tools preferred
Company
The Fountain Groups
The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program.
501-1000 employees
Funding
Current Stage
Late StageCompany data provided by crunchbase