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

Summary: IQVIA is hiring for a Data Acquisition Standards Associate, which is at a Principal, SME level. Join our sponsor-dedicated team working fully within the environment of a prominent pharma company. Be responsible for driving the data standards and governance of the Sponsor’s clinical data standards related to data acquisition and data collection. This role provides leadership for the continued development and enforcement of data standards, with focus on data acquisition standards, and collaborates extensively with Clinical Data Management and Clinical Programming.

In Collaboration with the Data Collection Standards, SDTM Standards, ADaM Standards, and Analysis Planning & Reporting Standards individuals, this role works to implement data standards after a downstream impact is assessed, maintaining consistency with the other data standard states to ensure accurate and seamless use of end-to-end data standards. The solutions will include managing the design of existing macros both for derivations within the clinical data pipeline and for data quality review purposes, and creation of and up-versioning of raw-plus mapping specifications.

Responsibilities:

• Collaborates with Clinical Data Management, Clinical Programming, and cross-functional study team members to identify new solutions in data standards that support the scientific need of a study/clinical program and ensures alignment with the data collection and acquisition strategy.

• With a wide breadth of knowledge in varying data types – including but not limited to EDC eCRFs, Direct Data Collection, eSource, and Non-eCRF data such as Central Labs, Imaging, and eCOA -- collaborates with Clinical Data Management in designing standard data validations for each data type.

• Consults with data source SMEs, process owners, and macro programming team questions related to clinical data pipeline derivations and standard data quality review listings.

• Implements and maintains study Raw-plus mapping specification resulting from updates to CRF and Non-CRF data sources.

• Maintains documentation associated to the standards, including but not limited to edit check specifications, data validation specifications and user guidance.

• Regularly meets with Data Collection Standards, SDTM Standards, ADaM Standards, and Analysis Planning & Reporting Standards subject matter experts to create holistic standard solutions for study/project teams while ensuring quality, consistency, and compliance to CDISC standards that supports the exchange of data. Implements future strategies and technology-enable processes and/or tools for the Clinical Data Standards.

• Serve as a subject matter expert on Data Acquisition and Raw-plus standards and may serve as subject matter expert on related tools/applications.

• Exhibits in-depth knowledge of clinical trial processes for data transformations, analysis, and governance.

• Creates quality control processes, metrics and other measures to ensure compliance with CRF and Non-CRF standards.

• Provides leadership through proper guidance and direction to technical individuals, including external vendors or third-party organizations to develop and implement strategies and/or tools.

Qualifications:

• BA / BS in Biology, Chemistry, Computer Science, Life Sciences, Clinical Data Management, Drug Development or equivalent.

• At least 6 years of relevant experience in a pharmaceutical, biotech or CRO setting. Demonstrated knowledge of clinical research, industry standards (CDISC), FDA & ICH, GCP, and related regulatory requirements.

• Experience in clinical programming and/or clinical data management experience with technical expertise in metadata management, standards management and implementation (CDASH, HL7) preferred.

• Experience in design, support of large-scale distributed databases and data standards administration.

• Knowledge of CDM best practices and tools (such as TrialGrid, Medidata Rave) and has a track record in applying knowledge to significantly improve efficiencies.

• Demonstrated extensive and in-depth understanding of various data types and how best to collect data based on its’ originating source.

• Experience and knowledge in all phases of clinical trials.

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. Learn more at https://jobs.iqvia.com

We are committed to providing equal employment opportunities for all, including veterans and candidates with disabilities. https://jobs.iqvia.com/eoe

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. https://jobs.iqvia.com/covid-19-vaccine-status

The potential base pay range for this role, when annualized, is $117,400.00 - $218,000.00. 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.