YCCI Validation Technical Project Manager

About the position

This role will be responsible for the management of Yale Center for Clinical Investigation's (YCCI) validation activities on various computer systems. The position involves validation and qualification of systems and processes in accordance with YCCI policies and/or regulatory requirements. Additionally, the role includes project management of YCCI technical projects, such as the configuration and testing of Electronic Data Capture systems and the development of tools to support Data Management, Project Management, and Monitoring activities. The position also requires developing processes and procedures to support compliance with YCCI and regulatory standards.

Responsibilities

• Oversees the execution and implementation of detailed project plans in concert with stakeholders.
• Manages several routine projects simultaneously and ensures that the 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.
• Five years of related work experience or equivalent combination of education and experience.

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.