YCCI Validation Technical Project Manager YSM Cores - YCCI 90829BR University Job Title Project Manager Bargaining Unit None - Not included in the union (Yale Union Group) Time Type Full time Duration Type Regular Compensation Grade Administration & Operations Compensation Grade Profile Manager; Program Leader (P6) 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 Work Model Remote Position Focus: Reporting to the Senior Associate Director, Systems and Project Management, this role will be responsible for: Management of Yale Center for Clinical Investigation’s (YCCI) validation activities on various computer systems. Validation/qualification of systems and processes in accordance with YCCI policies and/or regulatory requirements. Project management of YCCI technical projects (e.g. configuration and testing of Electronic Data Capture systems, development of tools to support Data Management/Project Management/Monitoring activities). Developing processes and procedures to support compliance with YCCI and regulatory standards. 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: Minimum of 5 years’ experience in a project management, business analyst, and/or computer systems validation role in a clinical research, government, or healthcare environment. Required Skill/Ability 2: Strong experience with creation of test cases, Validation Plans, and Validation Reports. Required Skill/Ability 3: Strong communication and writing skills. Required Skill/Ability 4: Excellent time management and planning skills. Preferred Education, Experience and Skills: Experience with computer systems used in clinical research (EDC, Clinicals Trials Management Systems, Electronic Master File Systems, etc). Knowledge of U.S. regulations related to validation activities and clinical databases. Experience with project management in a clinical research, government, or healthcare environment. Experience with Kneat or similar Computer Systems Validation software. Weekend Hours Required? No Evening Hours Required? No Drug Screen No Health Screening No 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. 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