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: Masters, PhD, PharmD or advanced degree in physical or natural science with 7 years of clinical trials experience; at least 5 years in a Regulatory capacity for an industry Sponsor or CRO strongly preferred; or an equivalent combination of education and directly relevant experience. Experience supporting INDs for novel imaging and radiotracer clinical translational first in human trials.
Preferred Education, Experience and Skills: Masters, PhD, PharmD or advanced degree in physical or natural science with 7 years of clinical trials experience; at least 5 years in a Regulatory capacity for an industry Sponsor or CRO strongly preferred; or an equivalent combination of education and directly relevant experience. Experience supporting INDs for novel imaging and radiotracer clinical translational first in human trials.
Required Skill/ability 5: Professionalism, maturity, good judgment, the ability to work with confidential material, excellent interpersonal, organizational, communication and project management skills are required. 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 Sr IND/IDE Clinical Trials Project Manager
Required Skill/ability 1: Previous experience working in Regulatory Affairs for an industry Sponsor or CRO managing FDA and/or EMA regulated clinical trials, and a deep understanding of, reflecting personal work experience managing INDs and/or IDEs, including managing FDA and/or EMA regulatory submission, regulatory communication, on-going management, and close-out.
Required Skill/ability 4: Comprehensive technical knowledge of FDA and EMA clinical trial regulations, in federal and state regulations for use of investigational new drugs and devices, proposal management and general research regulations, demonstrated through 5 or more years of direct experience in a Regulatory Affairs position managing multiple IND or IDE development programs.
Required Skill/ability 2: Experience in clinical trial management for FDA regulated industry-sponsored clinical trials, or a combination of education and experience. Knowledge of design and clinical research methods used in translational experimentation as well as previous experience in global regulatory strategic project management which includes IND/IDE management is expected.
Bachelor's Degree in a related field and five years of related work experience or equivalent combination of education and experience.
Internal Number: 65462BR
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.