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.
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