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 LanguagesEstimated Salary: $20 to $28 per hour based on qualifications.
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 LanguagesEstimated Salary: $20 to $28 per hour based on qualifications.
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