Job Id: 20210425011
Job Role: Sr. Clinical Database Developer
Experience: 7 Years
Job Location: Bangalore
Salary: Best in Industry
Vacancies: Not Mentioned
Job Description Stryker Careers Job Vacancy for Clinical Database Developer in April 2021:
As a lead Clinical Database Developer to manage and support all related functional tasks and project deliverables from single study assignments to large programs of studies. Manages multiple project timelines and deliverable. Designs, writes, validates, and maintains software to meet specifications. As a technical subject matter expert, supports clinical programming and Data Management staff for Electronic Data Capture (EDC), reporting, and processing tools. Proactively monitors internally and externally hosted applications for performance and/or system errors. Manages external application vendor issues, integrations, and implementations. May have supervisory responsibility and/or oversight for junior clinical programmers within a program.
Design the EDC specifications of trial build services for core configuration, eCRFs, data validations (DVS), custom functions and reporting
Develop configuration of the EDC trial by utilizing the trial design specifications for eCRFs, DVS, custom functions integrations and reporting
Perform EDC User and Site Administration to include site set up and assignment of roles, permissions and eLearning requirements
Implement and perform data integrations related activities to ensure data integrations meet project requirements
Collaborate with the project team to ensure the EDC configuration is completed on time with high quality
Collaborate with the project team to ensure data can be extracted easily from the back-end to support efficient downstream reporting and analysis
Provide Quality Control on deliverables developed by other team members or vendors
Maintain all required Configuration Specifications and Quality Control documents as required by SOPs and Processes
Collaborate with training team as an EDC Subject Matter Expert and perform training as necessary
Functions as an EDC Subject Matter Expert (SME) providing guidance and best practice recommendations to Data Management, operations teams and other stakeholders
As SME, is responsible to provide escalation of study specific functional issues, application/vendor issues, testing and validation needs, enhancement requirements, custom functions and/or custom reporting
Work on efforts related to EDC systems including UAT and global library/standards development
Ensure compliance with Stryker/industry quality standards, regulations, guidelines and procedures
Build, maintain and document the Medidata Rave global library standard objects (e.g., eCRF forms, edit checks) in order to facilitate the creation of study level databases to collect clinical trial data.
Work with Clinical Data Standards, Data Managers, and other EDC Database Developers to implement new or modified global library objects and to develop appropriate timelines for delivery of the global library objects.
Actively participate in and/or lead continuous improvement activities, defining and implementing the changes required to create an industry-leading electronic data capture capability.
Liaise with and review work delivered by external partners (e.g. Functional Service Providers, CROs, technology providers, etc.).
Other duties, as assigned.
What you need
Four-year college degree or higher, STEM preferred (Computer Science or Health related field) and/or equivalent work experience
Minimum 7 years in Pharmaceutical/Biotechnology/Medical Device industry or equivalent
Experience with requirements gathering, design and specification development of eCRFs, edit checks, and understanding of database structures and programming languages
Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities (SDLC) and CDISC standards (CDASH, SDTM)
Excellent verbal and written communication skills
Detail oriented, ability to multitask with strong prioritization, planning and organization skills
Excellent team player
Minimum 5 years’ experience with Medidata Rave platform, including Architect. Certified RAVE Developer highly preferred.
Custom Functions programming experience using C#
An understanding of database and dictionary structures (e.g. MedDRA, WHODrug).
Experience with Database programming is a plus: Oracle, SQL Server
Familiarity with other EDC Systems: Oracle InForm, IBM Merge preferred
Experience with Business Intelligence Tools: Business Objects, JReview, Cognos, or related preferred