Clinical database EDC programmer

EDC Design & Delivery

• Translate study protocol requirements into Electronic Data Capture (EDC) system design
• Ensure use of common data standards across studies
• Design EDC systems to optimize functionality, end-user experience, and data flow
• Own on-time delivery of EDC builds, amendments, and system changes
• Manage integrations between EDC and other systems (e.g., IRT)

Study & Program Execution

• Ensure TA- and program-level consistency across studies
• Track study progress using project management tools
• Anticipate risks to timelines or quality and develop mitigation plans
• Ensure work products align with upstream and downstream dependencies

Cross-Functional Collaboration

• Partner with DSS and cross-functional stakeholders to meet study and program objectives
• Influence team members without direct authority
• Participate in innovation and process-improvement initiatives

Compliance & Quality

• Ensure adherence to federal and local regulations
• Ensure compliance with GCP, ICH guidelines, SOPs, and quality standards
• Stay current on evolving regulations and clinical development policies

Core Requirements

• Medidata Rave Certification with 3+ years of hands-on study build experience
• Strong communication and presentation skills
• Ability to work in a fast-changing, evolving environment

Technical & Clinical Expertise

• 3+ years of clinical technology (EDC) experience or
• 5+ years in a similar technical or clinical development role
• Demonstrated understanding of the clinical trial process
• Knowledge of CDASH and SDTM
• Experience with common industry design and development tools
• Experience with EDC integrations (e.g., IRT)Professional Skills
• Strong analytical and problem-solving skills
• Ability to manage multiple priorities and timelines
• Proven ability to influence stakeholders without direct authority

Education

• Bachelor’s degree in Business, MIS, Computer Science, Life Sciences, or equivalent experience
• Master’s degree preferred, 1. Are you Medidata Rave Certified Study Builder? 2. How many years of experience do you have with EDC study builds?

$50 - $55 an hour - Full-time, Contract, Pulled from the full job description

• Referral program
• 401(k)
• Health insurance
• Vision insurance
• Dental insurance
• Opportunities for advancement, * Health insurance
• 401(k)
• Dental Insurance
• Vision Insurance
• Referral Program
• Travel Allowances, * 401(k)
• Dental insurance
• Health insurance
• Referral program
• Vision insurance

Founded in 1999, Mindlance has been ranked as one of the fastest growing US Staffing firms by SIA for 9 consecutive years. We provide Technology, Engineering, Digital / Creative / Marketing, Clinical Research, Scientific, Finance, Professional and Payroll Management staffing services to Global 1000 companies across the US, Canada and India.

Mindful of the opportunity gap, we provide balanced solutions for employers and job seekers. We empower job seekers with opportunities to advance their careers and enhance their skills while elevating recruitment standards and fostering a more mindful, balanced workplace.