POSITION DUTIES & RESPONSIBILITIES:Data Solutions Enablement has the responsibility to manage a full spectrum of data acquisition and processing applications covering data collected from Investigator sites, other data providers including digital data collection. DSE technical support also extends to the output side through to the delivery of data to downstream processes/systems for the purposes of review, analysis and reporting to regulatory submissions and dossiers. The off the shelf products or in-house application implementation demands the rigor of standardization and well-defined technical infrastructure to deliver a high level of quality, consistency, and efficiency with the required amount of flexibility to embrace the dynamic nature of pharma research and development. PRIMARY RESPONSIBILITIES:• Programming and implementation of apps and utilities to support clinical data projects and other data science applications as applicable• Lead setup & maintenance of integrations for data Import into and Export out of research and clinical systems.• Lead the setup of processes and technical program packages/apps to facilitate receipt of data from internal and external data providers using the available technology platforms• Coach and train user teams on integrations and platform implementations in context of data science and analytics• Manage integration business rules and interactions with internal and external business/technology partners• Design and execute software build responsibilities within the established technical standards and governance Major Tasks of Position: • Collaborates with colleagues in technical implementation for the software macros, tools and integrations within the team• Participates in software tool evaluation activities with software vendors and IT partners in context of operational implementation• Design and documentation of operational processes for adoption of new and updated integrations and technology aiming for process and technology connectivity across platforms• Implements technical setup for data review toolkits within existing end to end business processes• Execute validation activities related to tool and program packages release. Includes writing user acceptance test scripts, validation plans and associated reports• Collaborate with functional representatives to provide software related technical and process training• Provide support to business partners for software related audits/inspections by internal and external teams• Coach and mentor project teams on specific technical requirements post general availability of toolkit REQUIRED QUALIFICATIONS:• Master’s/Bachelor’s degree in a natural science, Statistics, Computer Science or a related field• 8-10 yrs of in-depth experience in programming on commonly used technology platforms for data analysis and reporting is required• Knowledge and experience in programming languages such as C++, SAS, R, Python, Java, PL SQL is required• Knowledge and experience project management 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 integration technology such as 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.
