Clinical Data Standards Officer

Location: Home-based in the U.S. or Canada

Summary & Responsibilities:

Join a sponsor-dedicated team to progress with the CDISC data standards initiatives of a Biopharma company. This role is responsible for developing and maintaining data standards for the collection of clinical study data, standard datasets and their related documentation. The incumbent will also contribute to the development of procedural documents to govern the processes around standards development and will be responsible for maintenance of the contents. In more detail the role will:

• Drive standardization of Data Management and Clinical Programming processes.

• Develop data standards and related documentation and manage the lifecycle of these standards.

• Project manage working groups in the development and revision of data standards.

• Update management on the status of clinical data standards working groups.

• Collaborate with stakeholders to develop standard electronic Case Report Forms (eCRF) in the eCRF system and associated documentation.

• Support the development of unique eCRF forms for new studies to ensure their compliance with the CDISC clinical data acquisition harmonization (CDASH) and SDTM data standards.

• Publish clinical data standards (e.g., templates, electronic data collection forms (eCRF), completion instructions mapping specifications) for internal users and CROs.

• Support the development of acceptance criteria for data deliverables and their documentation.

• Support Data Managers in the review of eCRFs for clinical studies and related documentation.

• Support Clinical Programmers in the review of standard datasets deliverables and related documentation for clinical studies and submissions to regulatory authorities.

• Ensure the quality and accuracy – thus submission readiness – of clinical data as required by authorities (i.e., follow the CDISC standard requirements).

• Serve as a Knowledge Expert to Clinical Development teams to supports electronic submissions to regulatory authorities with in-depth knowledge of applicable regulatory guidelines and standards. Ensure that clinical program teams consider applicable guidelines and standards in the clinical development plan by giving appropriate advice.

Qualifications:

• Degree (BSc/MSc/Diploma) in Computer Science, Mathematics/Statistics, or related area with relevant experience. Other degrees and certifications considered if commensurate with related data management or clinical programming experience.

• At least 8 years of experience in either clinical data management and/or statistical programming, within the CRO/pharmaceutical environment.

• Advanced knowledge in CDISC standards (CDASH, SDTM, ADaM).

• Must have a comprehensive understanding of data management processes and standards as well as current regulatory requirements for data management and data standards for submission.

• Must have a comprehensive understanding of interdependencies of processes in the clinical development process.

• Knowledge of at least one widely used CDMS and preferably experience of working with an EDC platform (Medidata Rave preferred).

• Proven ability to work effectively both independently or in a team setting, and to meet set goals by managing own 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 – to help our customers create a healthier world.  https://

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities.

IQVIA’s ability to operate and provide certain services to customers and partners necessitates IQVIA and its employees meet specific requirements regarding COVID-19 vaccination status.

The potential base pay range for this role, when annualized, is $115,300.00 - $196,200.00. The actual base pay offered may vary based on a number of factors including job-related qualifications such as knowledge, skills, education, and experience; location; and/or schedule (full or part-time). Dependent on the position offered, incentive plans, bonuses, and/or other forms of compensation may be offered, in addition to a range of health and welfare and/or other benefits.