IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.
Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.
Job Purpose
The Principal Clinical Data Standards Specialist is responsible for the development, maintenance and implementation of Industry (CDISC and regulatory) compliant Clinical Data Standards, providing expert support to business users and teams on their use in line with the Clinical Data Standards strategy.
Major Activities
Lead and contribute to Clinical Data Standards definition, development, validation and support within assigned standards discipline (domain) including the development and maintenance of associated metadata, documents, business rules and guidelines where applicable.
Define and deliver to robust, priority driven standards development plans for assigned area to ensure agreed deliverables are met and assigned resources are fully and effectively utilized.
Responsible for driving the efficient, high quality and timely implementation of new standards and / or updates to standards for :
a) Data Acquisition and Tabulation standards
b) Analysis and Reporting Data Standards
g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.
May represent sponsor within industry wide associations and working groups; contributing to regulatory guidelines, industry practices and professional standards development organizations such as CDISC, CFAST, PhUSE CSS, DIA etc.
In collaboration with representatives across Data Operations disciplines and key stakeholder and partner functions within GDO and across Global Drug Development, ensure the accurate translation of scientific and analytical requirements into efficient, compliant standards.
Support and ensure the appropriate and efficient governance and approval of global and project / study specific clinical data standards liaising with governance boards as needed.
Contribute to the technical review and assessment of industry and regulatory standards and guidelines supporting regular gap / impact analysis and implementation of action plans where needed.
Communicate effectively with the partners and customers; Establish and maintain strong collaborative relationships with Data Operations, Biostatistics and Clinical Development groups supporting the development and use of Clinical Data Standards.
Lead and contribute to the development, maintenance and training of relevant clinical standards systems and processes.
Act as an expert consultant providing Clinical Data Standards input to all relevant areas including; electronic data capture / database programming, edit check programming, report programming, electronic data loads, IVR technology, electronic patient reported outcomes, metadata management and / or other clinical data management or analysis data and TFL-related systems.
Act as subject matter expert (SME) for assigned area providing support, consultation and training to end users and SME networks on implementation of standards and related tools on development programs.
Provide mentoring and technical guidance to Clinical Data Standards associates.
Maintain up-to-date, expert knowledge of relevant technologies (EDC, software languages, applications etc.), Industry Standards (e.
g. CDISC, define.xml, eCTD etc.) and regulatory guidelines.
May represent Novartis within industry wide associations and working groups; contributing to regulatory guidelines, industry practices and professional standards development organizations such as CDISC, CFAST, PhUSE CSS, DIA etc.
As needed, act as a Clinical Standards representative supporting data standards governance, process improvement initiatives and / or other non-clinical projects.
Education
BS / BA / MS in computer science, management information systems, health sciences, statistics, or related field.
Languages :
Fluent English (oral and written).
Experience / Professional requirement :
EDC development and implementation preferably using Medidata-Rave
Data Management Clinical
Statistical Programming using SAS and CDISC data standards
Strong knowledge in one or more area of industry data standards and requirements including data acquisition, CDISC (CDASH, SDTM, ADaM), reporting and analysis, regulatory data submission.
Experience in supporting development of clinical standards and associated guidelines.
Data Acquisition and Tabulation
Data Analysis and reporting
Strong understanding and knowledge of regulatory requirements and industry standards relevant to data management and statistical programming (including GCP, ICH)
Good project management and coordination skills; Strong problem-solving, negotiation and conflict resolution skills.
Outstanding interpersonal and written and oral communication skills, with the ability to effectively communicate cross-functionally.
Strong understanding of drug development, global clinical trial / project practices, procedures, methodologies. Proven ability to provide and coordinate internal and external training (Experience working in highly matrix teams and providing technical guidance).
Experience contributing to non-clinical initiatives requiring Clinical Standards expertise preferable.
Join Us
Making a positive impact on human health takes insight, curiosity, and intellectual courage. It takes brave minds, pushing the boundaries to transform healthcare.
Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.
Forge a career with greater purpose, make an impact, and never stop learning.
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