YCCI Asst. Director, Clinical Data Management

24-Apr-2024

YSM Cores - YCCI - Protocol Design Development Feasibility

88010BR

Yale Posting Status

CLOSED TO FURTHER APPLICATIONS

University Job Title

Associate Director 4

Bargaining Unit

None - Not included in the union (Yale Union Group)

Compensation Grade

Administration & Operations

Compensation Grade Profile

Leader (27)

Wage Ranges

Click here to see our Wage Ranges

Searchable Job Family

Research Res Support

Total # of hours to be worked:

37.5

Work Week

Standard (M-F equal number of hours per day)

Work Location

Medical School Campus

Worksite Address

2 Church Street South Doctor's Building
New Haven, CT 06519

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.

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.

Required Skill/Ability 1:

Extensive experience working as a Clinical Data Manager and in all facets of study start- up/activation, on-going management of multiple protocols, study close-out, and regulatory submission. Ability to manage and lead a team.

Required Skill/Ability 2:

Experience with EDC, CTMS, and eTMF systems. Knowledge of 21 CFR Part 11 requirements.

Required Skill/Ability 3:

Experience in creating database specifications and building studies in one or more Electronic Data Capture (EDC) systems (e.g. Medidata Rave, Oracle InForm, IBM Clinical Development, Medrio, REDCap, etc.).

Required Skill/Ability 4:

Comprehensive technical knowledge of FDA and EMA clinical data standards and regulations, data management practices (GCDMP), and medical coding (MedDRA, WHODrug). Knowledge of SDTM data standards (CDASH, SDTM, ADaM).

Required Skill/Ability 5:

Experience with project management and computer validation projects. Professionalism, maturity, good judgment, and the ability to work with confidential material. The ability to work remotely; including an adequate workspace with internet access.

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).

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.

COVID-19 Vaccine Requirement

The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
https://covid19.yale.edu/health-guidelines

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.

EEO Statement:

University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.

Inquiries concerning Yale’s Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).

Note

Yale University is a tobacco-free campus