YCCI Asst. Director, Clinical Data Management
3 weeks ago
Essential Duties
1. Directs, monitors, and assesses needs and directs the application of resources of an administrative University office dealing with one or more major functional areas. 2. Directs and implements solutions to problems that are routine to complex in nature and that affect multiple functional areas of responsibility. 3. Plans and/or participates in planning University activities on a long-term basis to comply with University goals and objectives. 4. Establishes and implements consistent university-wide policies in multiple functional areas of responsibility. 5. Ensures that University office policies and procedures are in compliance with federal, state, and local laws and ordinances. 6. Develops and monitors goals and objectives for managerial and professional staff in compliance with University strategies. 7. Directs a staff of exempt and non-exempt employees. 8. May perform other duties as assigned.
Required Education and Experience
Bachelor'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. All offers are contingent upon the successful completion of the background check. 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. Supervise, train, mentor, and develop Clinical Data Management team to build skills and meet client expectations. Supervise and approve creation of database specifications and Electronic Data Capture (EDC) Case Report Form study builds. Develop, implement, and maintain libraries to support both industry, federal funding agencies, and YCCI internal data standards (CDISC, SDTM, ADaM, define.xml) 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. This position may require remote work on either a regular or temporary, part- time or full-time basis.
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. Employees will be assigned specific job-related duties through their hiring departments.
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