Job Description

The Study Designer/ Data Standards Expert is a multifaceted role within our organization, encompassing the responsibilities of both a Study Designer and a Data Standards Expert.

• They are responsible for creating the CRF study metadata in the MetaData Repository (MDR), leading all study set-up activities, and coordinating tasks and discussions between the CRO, internal study teams, and standards team. Additionally, they provide guidance on applicable/required changes to the Client Clinical Data Standards based on CDISC, Health Authorities, Transcelerate, other industry-related standards, and internal requests for modification and internal Data Model.

• Furthermore, the Study Designer/ Data Standards Expert takes the lead in testing the study in the electronic Data Capture (eDC) system, provides oversight of edit check programming conducted by the CRO, and prepares the CRF Completion guidelines. They collaborate with internal stakeholders, including Data Management, Stats/Programming, PK/PD and Biomarker departments, Clinical Operations, and Business Technology, to define and optimize data standards and processes.

• Furthermore, the Study Designer/ Data Standards Expert takes the lead in testing the study in the electronic Data Capture (eDC) system, provides oversight of edit check programming conducted by the CRO, and prepares the CRF Completion guidelines. They collaborate with internal stakeholders, including Data Management, Stats/Programming, PK/PD and Biomarker departments, Clinical Operations, and Business Technology, to define and optimize data standards and processes.

• As a Data Standards Expert, they possess extensive knowledge of Data Standard Governance and CDISC Data Standards and Tools. They also have comprehensive knowledge of CDISC CDASH, SDTM, ODM-XML, define.xml, with ADaM knowledge considered a plus. Their expertise includes validation procedures and quality assurance, as well as experience in leading or working in teams in a matrix and multicultural environment

The Study Designer/ Data Standards Expert is proficient in computer skills such as word processing and spreadsheets. They have knowledge of data management systems and/or programming languages, such as eDC, SAS, SQL. Familiarity with Oracle, Web-based EDC, and HTML is also advantageous. Their comprehensive understanding of ICH-GCP and major health authorities\' regulations, such as FDA, EMA, CFDA, PMDA, ensures adherence to regulatory requirements.

• In addition to their role as a Study Designer, the Data Standards Expert aspect of the position entails collaborating with internal stakeholders to provide guidance on changes to clinical data standards and participating in the publication, communication, and associated training of new/updated clinical data standards. They actively contribute to the assessment and selection of CROs and support CRO surveillance activities regarding standards compliance and quality of deliverables.

• The Study Designer/ Data Standards Expert is a key contributor to innovation initiatives, implementing strategies to support Client R&D with leading-edge applications and services that enhance speed and quality in drug development. They are involved in cross-functional and functional continuous improvement projects, including the re-engineering and implementation of processes, tools, technologies, conventions, standards, policies, Standard Operating Procedures (SOPs), and Working instructions (WIs).

• This role acts as an interface between business and Global Clinical Standards Initiatives, facilitating communication and collaboration. They interface with external vendors and partners on Data Monitoring, Management & Innovation related topics. The Study Designer/ Data Standards Expert possesses an excellent understanding of theories and practices in clinical data sciences, ensuring the highest standards of data quality and compliance.

Additional Responsibilities:

• Support the build of the eDC Client Library

• Maintain and manage the eDC Client library

• Manage the standards within MDR systems: CRF, Non-CRF, SDTM, and internal Data Model

• Support the validation of Non-CRF data

• Ensure the correct implementation of CRF, Non-CRF, SDTM Client standards at the study level

• Supports defining/maintaining a robust governance framework for clinical data standards and change management

• Supports the development, maintenance, optimization, and implementation of General and Therapeutic data standards (Clinical Data Collection (e.g. CRF and external data sources), CDISC/SDTM)

• Contribute to Governance Bodies (Data Standards), User Teams, and Advisory Boards if/as applicable

• Excellent understanding of trial activities and drug development, sound understanding of the Global Clinical Development function, as well as understanding of the pharma ethical business and commercial environment

• Provide expertise and guidance in eDC study design, ensuring alignment with data standards and best practices

• Collaborate with cross-functional teams to identify study-specific data collection requirements and design the eCRFs accordingly

• Lead the development of eDC study setup and configuration, including form design, edit checks, and user roles and permissions

• Coordinate with external vendors and partners to implement eDC systems and ensure seamless integration with data standards and processes

Strategic Impact

• Supports Client Clinical Data Standards and Therapeutic Area Standards development, optimization, and implementation

• Supporting and/or implementing CRO surveillance measures to ensure data standards quality for submissions and data pooling and timely dataset delivery

• Implementing eDC study design strategies aligned with data standards and best practices \xe2\x80\xa2 Collaborating with cross-functional teams to define study-specific data standards and requirements for high-priority development projects

• Providing expertise in eDC study design to ensure the quality of submission-relevant data deliveries to health authorities

• Contributing to process and technology improvement initiatives related to eDC study design \xe2\x80\xa2 Participating in high-priority projects with significant financial impact on the company\'s success

Education/Experience

• Degree in Life Sciences (e.g. biology, chemistry, pharmaceuticals), Mathematics or Computer Sciences or equivalent industry experience Work Experience

• Proven experience in the pharmaceutical/biotechnology industry, minimum of 10 years

• Proven experience in Data Standards Development and Governance

• Proven experience in development and implementation of Data Management functionalities, tools, workflows and validation procedures

• Proficiency in data management and eDC build

• Proven experience as a Data Standards Expert or related Data Management expertise in the pharmaceutical/biotechnology industry, equivalent to 8 years

• Experience in project leadership in the area of clinical data management or project leadership in the pharmaceutical/biotechnological industry, equivalent to 6 year

General:

• Extensive knowledge of Data Standard Governance

• Extensive knowledge of CDISC Data Standards and Tools

• Extensive knowledge of validation procedures and quality assurance

• Experience in leading or working in teams in a matrix and multicultural environment

• Proficient Computer Skills e.g. word processing, spreadsheets

• Excellent Knowledge of data management systems and/or programming languages, e.g. eDC, SAS, SQL

• Knowledge of Oracle, Web based EDC, HTML is a plus

• Comprehensive knowledge of CDISC CDASH, SDTM, ODM-XML, define.xml (ADaM is a plus)

• Comprehensive knowledge of ICH-GCP and major health authorities (e.g. FDA, EMA, CFDA, PMDA) regulations

• Excellent knowledge of regulations and guidance about clinical development and the systems used in this context

• Knowledge of medical terminology

• Experience in planning, set up and conduct of training material and activities and required tools

IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. We believe in pushing the boundaries of human science and data science to make the biggest impact possible \xe2\x80\x93 to help our customers create a healthier world. Learn more at

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