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Data Acquisitions Technical Expert

Data Acquisitions Technical Expert
Whippany, NJ, USA
Salary + Bonus + Paid Relocation
The DA Technical Expert will report to the Head of DA Technology & Integration and will be the Lead technical expert for the assigned platform/application and integrations supported within DAS. This will include the leadership of defining and managing associated business processes and functional representation for interactions with external data providers.
Responsibilities
o Lead the development of processes and implementation strategy for Medidata product suite (RAVE, SG, Designer Gateway, iMedidata) and other DAS applications as applicable
o Define and Lead setup and maintenance of integrations for Import into and Export out of data collection environment (ie RAVE)
o Lead the setup of processes and technical tools to facilitate receipt of data from internal and external data providers using the available technology platforms (ie LSH)
o Coach study teams on integrations implementations in context of study build, conduct and close out and on specific technical requirements post general availability of toolkit
o Define and Manage integration business rules and interactions with internal and
external business/technology partners
o Collect user requirements, setup and manage metric reports for study teams using standard platforms such as Business Objects, JReview, SAS.
o Lead software tool evaluation activities with software vendors and IT partners (ie, SIS, O&I, CTPS) in context of operational usage
o Design and document operational processes for adoption of new and updated integrations and toolkits aiming for process and toolkit connectivity across platforms
o Establish implementation strategy for data review toolkits within existing end to end business processes
o Plan and implement quality and reconciliation activities for integrations within studies
o Support implementation of reporting infrastructure and processes for usage in studies
o Business lead for validation activities related to tool and integrations release. May include overseeing testing, writing test scripts, validation plans and associated reports
o Collaborate with functional representatives to provide software related technical and process training
o Participate in industry initiatives to assess and further CI&A/DAS adoption of new technologies
oProvide support to business partners for software related audits/inspections by internal and external teams
o Understand and monitor the technical performance/metrics of the DAS tools and apply these finding to improve operational performance of tools
o Perform other duties as assigned.
REQUIREMENTS:
o Bachelor's Degree in Natural Sciences, Statistics, computer Science or Related field and with 10+ years of current, related, IT experience, or Master's degree in Natural Sciences, Statistics, computer Science or Related field and with 8+ years of current, related IT experience
o Must have 3-5 years of In-depth experience in design and developing tools and utilities on commonly used technology platforms (i.e. RAVE, LSH, Oracle Clinical) for data acquisition and associated review, and reporting (i.e., JReview, SpotFire)
o Strong knowledge and experience in programming languages such as C#, SQL, SAS
o Hands-on experience with the tools and utilities for the management of pharmaceutical sponsor proprietary or industry clinical data standards (i.e. sponsor specific or CDISC)
o Understanding of industry standards on integration technology such as web services and odm.xml
o Must have effective time management skills to ensure completion of assigned task within planned timelines
o Understanding of global regulatory requirements, rules and guidances' associated with Source Data in Clinical Investigations including CFR part 11
o Experience in comprehensive software validation activities using different methodologies (i.e. waterfall, agile etc.), inspections, analyses, and other verification tasks performed at each stage of the software development life cycle
o Effective written and verbal communication in English and usage of Microsoft Office
o Ability to think creatively in challenging and changing situations
o Willingness and ability to travel up to 10%
o Ability to work under stress and work on multiple competing priorities at one time and
o Must have authorization to be immediately employed within the United States long term.
Preferred Skills:
o Experience in project management tasks and managing multiple integrations and toolkits as assigned is desired and
o Effective interaction and training of teams in the understanding and usage of standards and technology is desired.
CANDIDATE MUST HAVE
IT Design & Development tools
Oracle Clinical
Programming Languages

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