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 a Project Manager for an industry Sponsor or CRO strongly preferred. Experience in clinical management systems is preferred. Experience implementing Electronic Health Record studies.
Preferred Education, Experience and Skills: Master's degree strongly preferred. 7 years of clinical trials experience as a Project Manager for an industry Sponsor or CRO strongly preferred. Experience in clinical management systems is preferred. Experience implementing Electronic Health Record studies.
Required Skill/ability 5: Professionalism, maturity, good judgment, and the ability to work with confidential material. The ability to work remotely; including an adequate workspace with internet access.
Posting Position Title: Project Manager
Required Skill/ability 3: Extensive knowledge of federal and state regulations protecting human subjects involved in research, demonstrated by five or more years of experience in an organization leadership position.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: YCCI Senior Clinical Trials Project Manager
Required Skill/ability 1: Previous experience working as a Project Manager for an 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 and protocols, study close-out, and regulatory submission.
Required Skill/ability 4: Comprehensive technical knowledge of FDA and EMA clinical trial regulations.
Required Skill/ability 2: Experience in clinical trial management for FDA regulated industry-sponsored clinical trials, or an equivalent combination of education and experience.
Bachelor's Degree in a related field and five years of related work experience or equivalent combination of education and experience.
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.