Support the Associate Director, Integration & Innovation to implement a roadmap for emerging digital technology (e.g. artificial intelligence, electronic health record, etc.) to drive client into next generation technology.
Facilitate in the development of a strategic roadmap for enhanced data mapping from source to reporting in both data visualization platforms and in delivery to the Quantitative Sciences (Biostatistics) business group.
Develop integration specifications and implement integration of both metadata and data point specific systems including, but not limited to, CTMS-like reporting metrics, vendor management oversight, sample tracking, eCONSENT, eCRF, AE/SAE safety indicators, etc. in order to provide a comprehensive user-friendly dashboard for predictive, risk-based monitoring of clinical trial information.
Create platforms and processes for GCDM process, including data flow maps where technology is utilized in the efficient and effective collection of all data sources which result in data review, visualization, and regulatory reporting.
Support the Data Standards lead in developing core CRF standards in a validated repository tool which includes ODM terminology and allows for visual presentation to stakeholders prior to CRF standards acceptance and EDC adoption.
Support an integrated rollout strategy for implementation of new processes, standards, and/or technologies to ensure clear scope, comprehensive communication, training, assessment, and continued improvement opportunities for internal personnel and outsourced provider(s).
Assess corporate goals and business strategies to identify opportunities for implementing new cross-functional/organizational policies and methodologies as related to process changes, data collection standards, and data visualization synergies.
Coordinate with strategic resourcing for the development of request for proposals (RFPs) for external vendor cross-functional/organizational contracts supporting GCDM data standards, process change and/or technology recommendations.
Serve as subject matter expert on regulatory audits for data standards and technical CDM activities.
Experience in clinical data management for a minimum of 5 years
Expert with the electronic data capture (EDC) system Medidata/RAVE .
Experience with data integrations between clinical databases and industry standard systems (e.g., CTMS, ePRO, IXRS, Argus).
Experience with data visualization tools (e.g., Spotfire, Looker, etc).
Experience in the design and validation of data collection instruments as well as data standardization, theory, design, collection, review, analysis, and display for implementation of standards across the Alexion organization.
Experience with oversight of:CDASH/CDISC (SDTM terminology), MedDRA and WHO-DD dictionary coding and versioning, SAS for data review, and software platforms across the biotechnology/pharmaceutical industry.
Possess a thorough knowledge of medical terminology and the clinical data management and the clinical trial process.
Experience on regulatory requirements for data management and the regulatory submission process.
Experience on developing request for proposals for external vendor contracts, and on evaluating external vendor contract for project procurement.
Experience in working on abstract problems across functional areas of the business, independently taking the appropriate corrective action, and identify and implement improvements. Able to review, interpret and evaluate clinical data.
Possess effective written and verbal communication skills necessary to interact with personnel at all levels within and external to the client.
Demonstrate initiative, sound judgment and flexibility; possess effective time management and organizational skills; and be able to work under deadlines and on multiple projects simultaneously.
Requires a Bachelor's degree in a scientific discipline, information technology discipline or equivalent.