
Clinical Data Development Professional
2 days ago
Senior Clinical Database Developer
Job DescriptionAs a senior clinical database developer, you will provide timely and professional management of data management/coding/CDDRA-database development/DAP deliverables and clinical trial data with respect. You will provide comprehensive expertise for multiple or complex global clinical studies, ensuring consistent and high-quality generation of specification, production, and validation of clinical data collection systems and associated metadata.
Responsibilities include serving as the primary study lead ensuring timely and quality deliverables, leading the effective and timely development and implementation of clinical systems for assigned studies, using advanced database programming techniques to solve study-specific complex validation or custom development needs, understanding and managing study metadata to complement data provisioning in compliance with global standards, coordinating database development and conducting database testing, developing data models to support data review and acquisition standards, establishing and maintaining strong working relationships with study teams and functional lines, and acting as a technical consultant ensuring appropriate development, maintenance, and use of all system capabilities.
Requirements:- At least 5 years of experience in setup of clinical databases/data warehouse using RAVE or OC-RDC or LSH
- Excellent interpersonal and written and oral communication skills
- Advanced technical skills, including expert knowledge of EDC-Medidata RAVE preferred
- Demonstrated ability to consistently produce detailed, high-quality deliverables in a team environment
- Excellent problem-solving, project management, negotiation, and conflict resolution skills
- Good understanding of drug development process, ICH-GCP, and health authority guidelines & regulations
- Clinical Data Management, Databases, Data Governance, Data Integrity, Data Management, Data Quality, Data Science, Waterfall Model
We are committed to reimagining medicine to improve and extend people's lives. We focus on developing innovative treatments and products that help millions of patients around the world access essential healthcare services.
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