Job Description

Job Title: Clinical Development Engineer (Medidata Rave / Technical Support)

Location : New Brunswick, NJ

Experience Level: 4 8 years

Employment Type: Full-Time / Contract

Position Overview

We are seeking a Clinical Development Support Engineer with deep technical expertise in Medidata Rave and related clinical data systems. The role involves supporting critical applications across the Clinical Development lifecycle , managing integrations, automations, and troubleshooting technical issues across application, database, and interface layers.

The ideal candidate will possess a mix of domain knowledge in Life Sciences and strong technical capabilities in SQL, Python, API integrations, and modern DevOps/automation tools.

Key Responsibilities

• Provide technical and functional support for Medidata Rave , including database-level analysis, configuration, user management, and issue resolution.
• Conduct advanced troubleshooting and root cause analysis for incidents, service requests, and integrations across the Clinical Development ecosystem.
• Manage support operations and ticket workflows using ServiceNow , ensuring adherence to SLAs and documentation best practices.
• Develop, optimize, and maintain SQL scripts and stored procedures in Microsoft SQL Server for reporting, validation, and data migration.
• Create and maintain Python scripts for automation, RPA support, and ad-hoc data processing.
• Work with RESTful APIs for integration, authentication, and data exchange between systems.
• Support Java-based authentication utilities (JAR files) and assist in integration troubleshooting.
• Design dashboards and reports using Tableau to support operational and analytical reporting.
• Perform data analysis and transformation using SAS for clinical and operational datasets.
• Utilize Git and Bitbucket for version control and code collaboration.
• Use Atlassian tools (Jira, Confluence, Bitbucket) for task management, documentation, and collaboration across teams.
• Manage cron-based automation schedules using VisualCron and perform basic MS-DOS command line operations for log reviews and file management.
• Participate in validation, change management, and release activities ensuring compliance with GxP and 21 CFR Part 11 .
• Document configurations, workflows, troubleshooting steps, and reusable scripts in Confluence or standard knowledge repositories.

Nice to Have

• SQL (Advanced Expert) : Complex query writing, joins, and performance optimization.
• Microsoft SQL Server (Intermediate) : Stored procedures and database management.
• Python (Intermediate) : Automation scripting, RPA, and data manipulation.
• Java (Basic) : Working knowledge of authentication modules and JAR handling.
• REST API (Intermediate) : Integration, data exchange, and debugging experience.
• Tableau (Intermediate) : Dashboard and visualization development.
• SAS (Intermediate) : Statistical or operational data analysis and reporting.
• Git (Intermediate) : Branching, merging, and code version management.
• Atlassian Suite (Intermediate) : Jira (task tracking), Confluence (documentation), Bitbucket (source control).
• VisualCron (Basic) : Job scheduling, monitoring, and automation setup.
• MS-DOS Command Line (Basic) : File navigation, scripting, and log handling.
• Experience with ServiceNow or equivalent ITSM/ticketing system.

Required Skills & Qualifications

• Bachelor's degree in Computer Science, Life Sciences, Bioinformatics, or related discipline .
• 4 8 years of experience in Clinical Development or Clinical Data Systems support.
• Strong hands-on experience with Medidata Rave (front-end and back-end).
• Excellent troubleshooting and root cause analysis skills across application and data layers.
• Strong communication, documentation, and cross-functional collaboration skills.

Preferred Qualifications

• Prior experience in pharmaceutical R&D or clinical data management environments.
• Familiarity with GxP , 21 CFR Part 11 , and other regulatory frameworks.
• Exposure to cloud platforms and integration monitoring tools.
• Experience with data visualization and automation initiatives supporting clinical operations.

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.

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