Are you looking to advance your career in the pharmaceutical and biotechnology industry? This Clinical Database Programmer role in Bangalore, Karnataka, offers a fantastic opportunity to work at the forefront of clinical data management. As part of a leading organization, you will play a pivotal role in implementing and supporting Medidata Clinical Cloud (MCC) solutions for global clinical trials. Join a team dedicated to innovation, collaboration, and excellence.
Responsibilities in the Job
As a Clinical Database Programmer, you will have a range of responsibilities critical to clinical trial success:
- Database Development and Testing: Design, develop, and test clinical databases, including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, custom functions, and both standard and custom reports.
- Peer Review: Perform peer reviews for studies built by other Clinical Database Programmers.
- EDC Standards Maintenance: Develop, maintain, and ensure compliance with database builds and electronic data capture (EDC) standards, including Global Library and CRF modules.
- Quality Deliverables: Manage timely, high-quality deliverables for study teams assigned to specific protocols/studies.
- EDC Subject Matter Expertise: Act as an EDC Subject Matter Expert (SME), providing guidance and best practices to Data Management and operations teams on Medidata Rave functionalities.
- Module Expertise: Gain working knowledge of additional Medidata Rave modules, including Coder, RTSM, Lab Admin, and iMedidata/Cloud Admin.
- Other Duties: Contribute to various additional tasks as assigned by management.
Qualifications
To excel in this role, candidates should possess:
- Educational Background: Bachelor’s degree or equivalent work experience (preferred).
- Industry Experience: 2+ years in the pharmaceutical/biotechnology industry or equivalent (preferred).
- Technical Expertise: Experience in requirements gathering, CRF design, edit checks, site queries, and database structures.
Skills
Professional Skills
- Creative and independent problem-solving skills.
- Strong communication and collaboration abilities.
- Exceptional attention to detail and multitasking capabilities.
- Proficiency in English for verbal and written communication.
Technical Skills
- Proficiency in Microsoft Office, particularly MS Project and MS Excel.
- Strong understanding of ICH/GCP guidelines, 21 CFR Part 11, and clinical trial methodologies.
- Programming skills in C#.
- Expert knowledge of Medidata Clinical Cloud (MCC), especially Rave EDC capabilities.
- Familiarity with ePRO, IVRS/IWRS, CTMS, and data reporting tools like Business Objects, JReview, Cognos, and Crystal Reports.
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