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 13 hours ago

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QAU Head -GLP INTOX Pvt. Ltd.

15.0 - 19.0 years

0 Lacs

pune, maharashtra

On-site

INTOX Pvt. Ltd. is a premier Indian toxicological Contract Research Organization (CRO) located in Pune. With OECD GLP Certification since 2007, INTOX operates in multiple areas including mammalian toxicology, bioanalytical studies, mutagenicity, environmental toxicity, analytical chemistry, and physical-chemical studies. This full-time on-site role is for a Head of Quality Assurance at INTOX Pvt. Ltd. in Pune. As the Head of Quality Assurance, you will be responsible for overseeing day-to-day quality control and quality auditing activities. Leveraging your analytical skills and expertise in quality management, you will ensure high-quality standards and compliance with regulations. Leading the Quality Assurance team and driving quality improvement initiatives will be key aspects of this role. Qualifications for this position include proficiency in Quality Control and Quality Auditing, strong analytical skills, experience in Quality Management and Quality Assurance, knowledge of relevant regulations and guidelines, excellent communication and leadership skills, ability to work effectively in a team, attention to detail, problem-solving abilities, experience in the CRO industry, and 15+ years of experience in QAU in a GLP environment. A Master's degree in Life Science along with a PhD is preferred.,

Posted 3 days ago

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