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.
1.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.
2.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.
3.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
4.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.
5.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.
6.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.
7.Communicate effectively with the partners and customers; Establish and maintain strong collaborative relationships with groups supporting the development and use of Clinical Data Standards.
Key Performance Indicator(s)
1.Achieve overall goals as set each year by Group Head Clinical Standards.
2.Achieve high level of quality, timeliness and customer satisfaction on Clinical Data Standards activities and deliverables.
3.Achieve high levels of effective collaboration, customer satisfaction on support and training provided within discipline / area.
4.Achieve minimal number of post-production changes resulting from Clinical Data Standards issues.
5.No critical findings as result of routine audits or health authority inspections relating to activities / deliverables supported by the Clinical Standards Group.
BS / BA / MS in computer science, management information systems, health sciences, statistics, or related field. Fluent English (oral and written).
a.EDC development and implementation preferably using Medidata-Rave
b.Data Management Clinical
c.Statistical Programming using SAS and CDISC data standards
2.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.
3.Experience in supporting development of clinical standards and associated guidelines.
a.Data Acquisition and Tabulation
b.Data Analysis and reporting