Support implementation of Medidata and Oracle product suite (Oracle database, LSH, DMW, RAVE, SG, iMedidata, Patient Cloud, etc.) and other DS&A applications as applicable for use in clinical trials managed by DS&A
Support setup and maintenance of integrations in studies for data Import into and Export out of RAVE, LSH, DMW
Design and execute project implementation responsibilities within the established technical standards and governance
WHAT YOU DO:
Support technical implementation for the software tools and integrations within DS&A
Support software tool evaluation activities with software vendors and IT partners in context of operational implementation
Support technical interactions with external technology partners to maintain systems including enhancements and further development for DS&A technology platforms.
Monitors data processing and review toolkits within existing end to end business processes to ensure successful scheduled execution
Implement quality and reconciliation activities for integrations to ensure uninterrupted data flow within studies
Support validation activities related to tool and program packages release. Includes writing user acceptance test scripts, validation plans and associated reports
Estimates the time and resources needed to complete assignments. Tracks work progress and provides periodic status reports to supervisor and team members
Provide support to business partners for software related audits/inspections by internal and external teams
WHO YOU ARE:
Masterâs/Bachelorâs degree in a natural science, Statistics, Computer Science or a related field
4-6 yrs of in-depth experience in programming on commonly used technology platforms (ie RAVE, LSH, Oracle Clinical, DMW) for data acquisition and associated review, and reporting (i.e., JReview, SpotFire) is required
Knowledge and experience in programming languages such as C#, SQL, SAS, PL SQL is required
Knowledge in clinical trial start up, conduct and close out activities and associated technical best practices
Hands-on experience with the technology platforms & utilities for the management of pharmaceutical sponsor proprietary or industry clinical data is required
Understanding of industry standards on digital data integration technology such as APIs, web services and odm.xml is also required.
Effective time management skills to ensure completion of assigned task within planned timelines is required
Understanding of global regulatory requirements, rules and guidance associated with Source Data in Clinical Investigations including CFR part 11 is required
Experience in project management tasks and managing multiple integrations and toolkits as assigned is desired
Experience in comprehensive software validation activities using different methodologies (ie waterfall, agile etc),inspections, analyses, and other verification tasks performed at each stage of the software development life cycle is required
Effective interaction and training of teams in the understanding and usage of standards and technology is desired
Effective written and verbal communication in English and usage of Microsoft Office is also necessary
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve peopleâs lives? Then send us your online application including cover letter, CV and references.
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