Principal Data Acquisition Standards SME

Principal Data Acquisition Standards SME

Home-based anywhere in United States or Canada

Why DSSS?

Data Sciences Staffing Solutions, DSSS or DS3, is a unit within IQVIA that provides our sponsors with fully dedicated resources through a Functional Service Provider (FSP) partnership. This means you get all the benefits of working for an industry leading CRO while operating within a sponsor environment and utilizing sponsor systems. Being part of DSS means being part of a passionate team dedicated to advancing medicine and reshaping healthcare. Your role will be both challenging and rewarding, making a real impact.

Experience the best of both worlds and become a core part of our dynamic team today!

Position Overview:

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.
• Minimum 8 years of recent Data Standards experience in a pharmaceutical, biotech, or CRO setting.
• Demonstrated knowledge in all phases of clinical trials, industry standards (CDISC), FDA, ICH, GCP, and other related regulatory requirements.
• Experience in clinical programming, R programming, or clinical data management with technical expertise in metadata management, standards management, and implementation (CDASH, HL7) strongly 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.
• Ability to work in a fast-paced environment