Senior Medidata Consultant Developer (EDC & Coder)

Job Title: Senior Medidata Consultant / Developer (EDC & Coder)

Location : New Brunswick NJ

Experience Level: 6 10 years

Employment Type: Full-Time / Contract

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

• Bachelors or Masters 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.

Tekshapers is an equal opportunity employer and will consider all applications without regards to race sex age color religion national origin veteran status disability sexual orientation gender identity genetic information or any characteristic protected by law.