Job Description

IQVIA is looking for a detail-oriented and highly organized Clinical Data Archiving Specialist to manage the archiving and preservation of our Sponsor\'s organization clinical data assets. The Clinical Data Archiving Specialist will play a critical role in ensuring the secure and efficient storage of clinical data, implementing clinical data retention policies, and adhering to industry regulations and best practices. The ideal candidate should have a strong understanding of clinical data management principles, archiving methodologies, and data privacy and security. Experiences in submission of CDISC deliverables to health authorities (eg, FDA, PMDA) is a plus.

Main Responsibilities and Accountabilities:

• Develop and implement clinical data archiving strategies and policies to efficiently manage the organization\'s data assets throughout its lifecycle.
• Identify and categorize clinical data based on its relevance, sensitivity, and regulatory requirements to determine appropriate archiving procedures.
• Collaborate with cross-functional teams, including regulatory, Statistical Programming & Biostatistics, Data Management, to ensure alignment with clinical data retention policies and industry regulations.
• Establish and maintain clinical data archiving procedures, including metadata management, to ensure data integrity and accessibility.
• Evaluate and select archiving solutions and technologies, including cloud-based and on-premises options, to meet the organization\'s data storage needs.
• Perform regular clinical data archiving audits and validation checks to verify the completeness and accuracy of archived data.
• Provide support and guidance to internal stakeholders regarding clinical data archiving best practices, policies, and procedures.
• Assist in or lead the development and maintenance of data archiving documentation, including archiving plans, policies, and process flows for clinical assets.
• Collaborate with data owners and users to define data access rights and permissions for archived clinical data.
• Implement data restoration processes to retrieve and restore archived data when required for business or regulatory purposes.
• Stay up-to-date with industry trends and best practices related to clinical data archiving.

Education

• As a minimum, Bachelor\'s degree in Computer Science, Information Technology, Medical Documentation/Archiving or a related field.
• Other degrees and certifications considered, if commensurate with related clinical data archiving or data management experience.

Experience

• Has considerable experience in clinical data archiving and/or clinical data management, within the CRO/pharmaceutical environment. Certifications in data archiving (e.g., Certified Data Archiving Professional) are a plus.
• Has knowledge of at least one widely used Clinical Data Management or Clinical Data Warehouse system.
• Strong knowledge of data archiving methodologies, data lifecycle management, and data privacy and security principles.
• Familiarity with industry regulations and standards related to data archiving, such as GDPR
• Ideally, knowledge in CDISC standards (CDASH, SDTM, ADaM) and experience in the implementation of CDISC standards and submission of CDISC data packages to health authorities (FDA, PMDA).
• Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing timelines.
• Experience in working in cross-functional, multi-cultural and international clinical trial teams.

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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