Principal Clinical Data Standards Specialist
Nov Hltcr Shared Services Ind
Hyderabad, AP, India
3d ago

Position 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 Accountabilities

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

  • Standards in clinical systems including EDC, MDR and other global standards libraries including robust testing and validation
  • Compliant data models to support the use and transformation of data acquisition, tabulation and review standards (including associated metadata).
  • Use advanced database programming techniques to support the implementation of efficient data collection tools.
  • Processes, tools and guidelines relating to the submission of standardized acquisition / tabulation data supporting regulatory submission.
  • b.Analysis and Reporting Data Standards

  • Compliant analysis and reporting standards (ADaM and TFL)
  • Use advanced programming knowledge to support specification of new analysis and reporting tools (incl. standard macros)
  • Data models to support data analysis (ADaM) and reporting (TFL) standards (including associated metadata).
  • Processes, tools and guidelines relating to the submission of standardized analysis data supporting regulatory submission.
  • 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.

    Minimum requirements

    BS / BA / MS in computer science, management information systems, health sciences, statistics, or related field. Fluent English (oral and written).

  • 1.At least 6 years industry experience in one of the following fields;
  • 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.

  • 4.Expert technical skills relevant to;
  • a.Data Acquisition and Tabulation

  • Good knowledge of EDC systems (preferably including Medidata-Rave)
  • Good knowledge in Object Oriented Programming concepts
  • Knowledge of other programming languages such as Visual Basic, SQL-PL / SQL and C# or Java preferable
  • b.Data Analysis and reporting

  • Good knowledge of SAS and other statistical programming languages / software (e.g. R)
  • Good understanding of statistical programming
  • Apply
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