Internal Medicine - Cardiology
University Job Title
Project Manager
Bargaining Unit
None - Not included in the union (Yale Union Group)
Compensation Grade
Administration & Operations
Compensation Grade Profile
Manager; Program Leader (P6)
Wage Ranges
Click here to see our Wage Ranges
Searchable Job Family
Administration, Business Operations, Research Res Support, Research/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
127-153 College Street
New Haven, CT 06510
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. Supervise, train, mentor, and develop Data Management team to build skills and meet client expectations. Supervise and create database specifications and Electronic Data Capture (EDC) Case Report from study builds. Develop, implement, and maintain libraries to support both industry and YCRG internal data standards (e.g., CDISC SDTM). 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 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. This position may require remote work on either a regular or temporary, part-time or full-time basis.
Essential Duties
1. Oversees the execution and implementation of detailed project plans in concert with stakeholders. 2. Manages several routine projects simultaneously and ensures that the design, testing, training, documentation and prioritization objectives are met. 3. Assists in refining and re-sequencing during the implementation and execution phases of assigned projects, as needed. 4. Works closely with business analysts, technical professionals, end users and project stake holders during the requirements, solutions design and implementation phases to develop detailed project plans for implementation. 5. Works on risk assessment, communication planning, development of performance metrics, and project entry criteria. 6. Creates detailed project plans including timelines, budgets, and resource allocation to ensure successful project completion. 7. Manages client expectations and provides issue/risk identification and escalation pathways. 8. May supervise the implementation team of cross-functional project and technical resources. 9. Designs, develops, and executes communication systems to ensure effective exchange of information between project stakeholders, senior management, and staff. 10. Resolves complex project issues that involve representatives from multiple organizations. 11. Complies with standard policies and procedures. 12. May supervise and train junior project managers. 13. May perform other duties as assigned.
Required Education and Experience
Bachelor’s Degree in a related field and five years of related work experience or equivalent combination of education and experience.
Required Skill/Ability 1:
Demonstrated experience working as a Data Manager for an industry Sponsor or CRO or ARO managing FDA and/or EMA-regulated clinical trials. Extensive experience 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:
Demonstrated experience with EDC, CTMS, and eTMF systems. Knowledge of 21 CFR Part 11 requirements.
Required Skill/Ability 3:
Demonstrated 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:
Demonstrated experience with project management and computer validation projects. Professionalism, maturity, good judgment, and 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. 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.).
Weekend Hours Required?
Occasional
Evening Hours Required?
Occasional
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