Senior Clinical Data Standards Consultant ICON Strategic Solutions

2.0 - 6.0 years

0 Lacs

karnataka

On-site

As a Data Standards Specialist at ICON plc, you will play a crucial role in supporting the standardization of data management practices. Your primary responsibility will involve creating and maintaining content in the Data Standards Catalog under guided supervision. You will collaborate with representatives from various functions, leveraging industry standards to develop clinical data collection instruments and associated checks. Your role will also involve updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. Participation in relevant governance team meetings and providing input on standards as assigned will be essential. Collaborating with Senior/Principal Data Standards Specialists or Managers to implement data standards strategy, ensuring compliance with regulations and internal governance procedures will be part of your responsibilities. As a subject matter expert (SME) for specific topics, you may provide ongoing support to the Data Management organization and key stakeholders such as Clinical, Biostatistics, Medical, and Medical Writing departments. Additionally, you will contribute to Data Management or cross-functional initiatives as needed and oversee CRO/FSP data managers and/or database development teams. You will represent the Data Standards team in various forums, including Data Standards Governance meetings, Clinical study team meetings, and Project update meetings. Demonstrating a foundational knowledge of Data Management and Data Standards processes, along with an awareness of industry best practices, is key to excelling in this role. Having a basic understanding of regulations like 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards for data collection is required. An ideal candidate would have a minimum of 2 years of clinical data standards experience in the biotechnology, pharmaceutical, or health-related industry. Possessing CDISC standards, SCDM certification, or Medidata RAVE certification is considered a plus. The role requires a Bachelor's degree in a Science, Health, Computing, or related field. At ICON, we value our employees and offer a competitive salary along with a range of benefits designed to promote well-being and work-life balance. Our benefits include various annual leave entitlements, health insurance options, retirement planning offerings, a Global Employee Assistance Programme, life assurance, and country-specific optional benefits like childcare vouchers, discounted gym memberships, and health assessments. To learn more about the benefits of working at ICON, visit our careers website at https://careers.iconplc.com/benefits. If you are interested in the role but unsure if you meet all the requirements, we encourage you to apply as you may be exactly what we are looking for at ICON, whether for this position or other roles.,

Posted 1 week ago

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Clinical Data Standards Consultant ICON Strategic Solutions

2.0 - 6.0 years

0 Lacs

karnataka

On-site

ICON plc is driving efficiencies through standardizing data management practices. As a Data Standards Specialist, you will play a crucial role in creating and maintaining content in the Data Standards Catalog. Working under guided supervision, you will collaborate with representatives from various functions to develop clinical data collection instruments and checks using industry standards. Your responsibilities will include updating metadata definitions and specifications in alignment with CDISC Study Data Tabulation Model (SDTM/CDASH) and controlled terminology. You will actively participate in governance team meetings, providing input on assigned standards. Collaborating with Senior/Principal Data Standards Specialists or Managers, you will help implement data standards strategy while ensuring compliance with regulations and internal governance procedures. In addition, you may serve as a subject matter expert (SME) for specific topics. You will offer ongoing support to the Data Management organization and key stakeholders such as Clinical, Biostatistics, Medical, and Medical Writing teams. Your role may also involve contributing to Data Management or cross-functional initiatives as required. Furthermore, you might oversee and hold accountable CRO/FSP data managers and/or database development teams. As part of the Data Standards team, you will represent ICON in various forums including Data Standards Governance meetings, clinical study team meetings, and project update meetings. To be successful in this role, you should demonstrate a foundational knowledge of Data Management and Data Standards processes, along with an understanding of industry best practices. A basic understanding of regulations such as 21 CFR Part 11, ICH-GCP Guidelines, and CDISC standards is required. Possession of CDISC standards, SCDM certification, or Medidata RAVE certification will be advantageous. A minimum of 2 years of clinical data standards experience in biotechnology, pharmaceutical, or health-related industry is necessary. Education-wise, a Bachelor's degree in a Science, Health, Computing, or related field is required. At ICON, we value our people and strive to build a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, we offer a range of benefits tailored to promote well-being and work-life balance for you and your family. Our benefits include various annual leave entitlements, health insurance options, retirement planning offerings, a Global Employee Assistance Programme, life assurance, and country-specific optional benefits like childcare vouchers, gym memberships, and health assessments, among others. If you are interested in the role but unsure if you meet all requirements, we encourage you to apply as you may be exactly what we are looking for at ICON. Visit our careers website to learn more about the benefits of working with us: https://careers.iconplc.com/benefits For more information about reasonable accommodations, visit: https://careers.iconplc.com/reasonable-accommodations,

Posted 1 week ago

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