Senior Medidata Consultant

Contractor

Job Title: Senior Medidata Consultant / Developer (EDC & Coder)
No. of Positions – 1
Preferred Primary Location: Offshore – India Pune, Noida, Bengaluru, Chennai, Hyderabad
Experience Level: 6–10 years
Employment Type: Full-Time

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 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.