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YCCI Asst. Director, Clinical Data Management - New Haven, United States - Yale University
Description
Essential DutiesBachelor's Degree in related field and eight years of experience or an equivalent combination of education and related experience.
Background Check Requirements
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 YCCI managed studies under the leadership of the Sr. Associate Director of Research Operations.
Provide CDM expertise for multiple projects to meet the needs of clinical research studies, including overseeing data standards development, validation activities, monitoring project timelines, and communicating with stakeholders.
Develop, implement, and maintain libraries to support both industry, federal funding agencies, and YCCI internal data standards (CDISC, SDTM, ADaM, ) and data collections standards in 21 FDA Part 11.
Support Investigators in meeting study reporting requirements include data sharing requirements. Work collaboratively with internal and external teams to implement eSource data projects (e.g. integration of EHR and other external data sources).Identify opportunities to build process efficiencies and increase data quality, and work collaboratively with teams who have studies in development through full operational deployment, and closeout as it relates to CDM needs.
As an integral member of the Clinical Data Management Team , 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 which identify, prevent, and appropriately mitigate clinical 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 (YCCI), Biostats (YCAS), and EHR research team (JDAT); clinical trials sponsors and vendors; and with research teams at other academic centers.
Familiar 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. Project Management Professional (PMP). Certified Clinical Data Manager (CCDM). 10+ years Clinical Data Management experience in industry or CRO. SQL & SAS programming skills (Base, Macro, ODS). Experience with eCTD data submissions, FHIR, data integration from EHR systems (e.g. Epic) and other eSource data sources (Direct Data Capture, eCOA/ePRO).
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.
