YCCI Validation Technical Project Manager

Yale University - New Haven, CT

Full-time - Mid Level

New Haven, CT

Educational Services

About the position

The YCCI Validation Technical Project Manager at Yale University is responsible for overseeing the validation activities of various computer systems within the Yale Center for Clinical Investigation (YCCI). This role involves project management of technical projects, ensuring compliance with YCCI policies and regulatory requirements, and developing processes to support data management and project management activities. The position requires strong communication and organizational skills to manage multiple projects and collaborate with various stakeholders.

Responsibilities

• Oversees the execution and implementation of detailed project plans in concert with stakeholders.
• Manages several routine projects simultaneously and ensures that design, testing, training, documentation, and prioritization objectives are met.
• Assists in refining and re-sequencing during the implementation and execution phases of assigned projects, as needed.
• Works closely with business analysts, technical professionals, end users, and project stakeholders during the requirements, solutions design, and implementation phases to develop detailed project plans for implementation.
• Works on risk assessment, communication planning, development of performance metrics, and project entry criteria.
• Creates detailed project plans including timelines, budgets, and resource allocation to ensure successful project completion.
• Manages client expectations and provides issue/risk identification and escalation pathways.
• May supervise the implementation team of cross-functional project and technical resources.
• Designs, develops, and executes communication systems to ensure effective exchange of information between project stakeholders, senior management, and staff.
• Resolves complex project issues that involve representatives from multiple organizations.
• Complies with standard policies and procedures.
• May supervise and train junior project managers.
• May perform other duties as assigned.

Requirements

• Bachelor's Degree in a related field and five years of related work experience or equivalent combination of education and experience.
• 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.
• Strong experience with creation of test cases, Validation Plans, and Validation Reports.
• Strong communication and writing skills.
• Excellent time management and planning skills.

Nice-to-haves

• Experience with computer systems used in clinical research (EDC, Clinical 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.