Senior Medidata Consultant / Developer

Job Title: Senior Medidata Consultant / Developer (EDC & Coder)
Location: Onsite – New Jersey, US
Experience Level: 6–10 years

Position Overview
We are seeking a Senior Medidata Consultant / Developer with extensive experience in Medidata EDC (Rave) and Medidata Coder platforms to support, enhance, and optimize clinical trial data management systems.
The ideal candidate will possess a strong understanding of clinical data workflows, along with solid technical troubleshooting, configuration, and integration expertise. This role involves close collaboration with global clinical operations, data management, and IT teams to ensure seamless system performance and data quality throughout the clinical lifecycle.

Key Responsibilities
 Serve as a subject matter expert (SME) for Medidata EDC and Medidata Coder,
overseeing configuration, deployment, and maintenance across multiple clinical
studies.
 Lead the design, development, and implementation of enhancements, custom
configurations, and integrations within Medidata platforms.
 Conduct advanced troubleshooting and root cause analysis for complex
application and data-related issues, ensuring minimal disruption to business
operations.
 Support system integrations with downstream and upstream applications (e.g.,
CTMS, RIM, Safety, and BI tools).
 Collaborate with clinical data management teams to optimize data capture, coding
accuracy, and study setup within EDC.
 Partner with Medidata vendor teams and internal IT to manage releases, patches,
and validation activities.
 Develop and maintain technical documentation, SOPs, and configuration guides in
line with regulatory and compliance requirements.
 Provide guidance and mentorship to junior team members and participate in cross-
functional knowledge sharing.
 Ensure all solutions comply with GxP, 21 CFR Part 11, and corporate validation
policies.
 Actively contribute to continuous improvement initiatives, automation opportunities,
and process efficiency enhancements.

Required Skills & Qualifications
 Bachelor’s or Master’s degree in Computer Science, Life Sciences, Information
Systems, or related discipline.
 6–10 years of experience in Clinical Development IT, with at least 4+ years of
hands-on experience in Medidata EDC (Rave) and Medidata Coder.
 Proven expertise in system configuration, data model understanding,
and clinical trial setup within Medidata platforms.
 Strong troubleshooting and analytical skills, with the ability to diagnose complex
issues across application, data, and integration layers.
 Good understanding of clinical data management workflows, medical coding
standards (MedDRA, WHO Drug), and CDISC/CDASH concepts.
 Experience with API integrations, SQL, and scripting (Python or SAS) for
automation or data validation preferred.
 Familiarity with ticketing and documentation systems such as ServiceNow, Jira,
and Confluence.
 Excellent communication and stakeholder management skills, with the ability to
interact effectively with business, IT, and vendor teams.
 Strong documentation discipline, adhering to validation and compliance processes.

Preferred Qualifications
 Experience in pharmaceutical or CRO environments managing global trials.
 Knowledge of Medidata Rave Architect, Rave Web Services (RWS), and
integration with downstream systems.
 Exposure to automation tools and data analytics platforms such
as Tableau or Spotfire.
 Understanding of SDTM, ADaM, or other clinical data standards.