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.
Preferred Education: Master's degree strongly preferred. 7 years of clinical trials experience as an auditor, clinical research associate or equivalent for an industry Sponsor or CRO strongly preferred. Experience in clinical management systems is preferred.
Preferred Education, Experience and Skills: Master's degree strongly preferred. 7 years of clinical trials experience as an auditor, clinical research associate or equivalent for an industry Sponsor or CRO strongly preferred. Experience in clinical management systems is preferred.
Required Skill/ability 5: Superior interpersonal, oral and written communications skills and ability to work effectively with a wide variety of external and internal stakeholders.
Posting Position Title: Project Manager
Required Skill/ability 3: Extensive knowledge and application of auditing and monitoring techniques and practices. Professionalism, maturity, good judgment, and the ability to work with confidential material. The ability to work remotely; including an adequate workspace with internet access.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Lead Clinical Research Associate
Required Skill/ability 1: Experience as auditor, clinical research associate or equivalent for industry Sponsor or CRO managing FDA and/or EMA regulated clinical trials. Extensive experience in all facets of study start-up/activation, external site feasibility, participant enrollment, on-going management of multiple-external sites & protocols, study close-out, & regulatory.
Required Skill/ability 4: Self-directed with the ability to work, plan, research, and conduct projects with minimal supervision and on a flexible schedule. Organized and capable of handling multiple/diverse projects simultaneously.
Required Skill/ability 2: Comprehensive understanding of clinical research review, approval and Data and Safety Monitoring processes. Comprehensive knowledge of federal regulations concerning the protection of human subjects and clinical trial design, implementation and analysis.
Bachelor's Degree in a related field and five years of related work experience or equivalent combination of education and experience.
Internal Number: 63886BR
About Yale University
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.