Clinical Database Programmer

Job Title:

Clinical Systems / EDC Specialist (Medidata Rave)

Location:

Lake County / Irvine / Florham Park (Hybrid preferred; remote acceptable

Contract Length: 1 year

Data Science is a best-in-class team responsible for bringing people, process, and technology together to generate business value from clinical trials data. The team operates through execution and innovation to support program- and study-level accountabilities within Data and Statistical Sciences (DSS).

• 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)

• 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

• 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

• 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

• 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

• 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)

• Strong analytical and problem-solving skills
• Ability to manage multiple priorities and timelines
• Proven ability to influence stakeholders without direct authority

• Bachelor’s degree in Business, MIS, Computer Science, Life Sciences, or equivalent experience

EEO:

“Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of – Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.”