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Assistant Director of Clinical Data Management - New Haven, United States - Yale University
Description
Essential Duties
Bachelor's Degree in a related field and five years of related work experience or equivalent combination of education and experience.
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements.
For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.
Position Focus:
Lead all Clinical Data Management (CDM) activities for Yale Cardiovascular Research Group (YCRG) studies under the leadership of the YCRG Director.
Provide CDM expertise for multiple projects, including multi-site projects, to meet the needs of clinical research studies, including overseeing data standards development, validation activities, monitoring project timelines, and communicating with stakeholders.
Identify opportunities to build process efficiencies, and improve and expand process documentation (e.g., Standard Operating Procedures), and increase data quality.
As an integral member of the YCRG academic research organization, the position ensures an environment that promotes quality research management and facilitates interdisciplinary research activities.
The Assistant Director of Clinical Data Management further promotes a compliant culture appropriate for a large physician organization with clinical affiliations across multiple academic and non-academic medical centers including coordinating initiatives that identify, prevent, and appropriately mitigate multisite trials and FDA Part 11 research system compliance risk, and ensure that YSM, YM, YNHH compliance efforts align with the university's broader compliance strategy and framework.
The position coordinates effectively with other units/departments within the university such as Project Management (YCRG), Biostats (YCRG and YCAS), and EHR research team (JDAT); clinical trails sponsors and vendors; and with research teams at other academic centers.
Familiarity with a variety of the field's concepts, practices, and procedures and relies on experience and judgment to plan and accomplish goals.
Preferred Education, Experience and Skills:
Master's degree preferred. Cerfied Clinical Data Manager (CCDM). 10+ years Clinical Data Management experience in industry or CRO. SQL & SAS programming skills (Base, Macro, ODS). Proven experience with eCTD data submissions, FHIR, and data integraon from EHR systems (e.g. Epic) & other eSource data sources (Direct Data Capture, eCOA/ePRO, etc.).
Posting Disclaimer
The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position.