Manages special projects ranging from academic to financial from inception to completion, which requires quantitative analysis, independent research, and the proposal of resolutions or conclusions. Creates and envisions programmatic initiatives and communication strategies. 2. Designs and develops communications strategies for special projects. Develops and exercises a keen understanding of the multiple audiences and contributing University offices involved in a given project to ensure that individual communications are rolled out within a structure planned in advance and with appropriate communication among key stakeholders. 3. Envisions, creates and authors a wide variety of sensitive and high-level written materials. Serves as coordinator and executor for a range of internal and external committees. May participate in decisions regarding committee work. Advises panelists on precedents and prior actions. 4. Serves as Secretary for committee(s), manages informal and formal resolution processes and voluminous correspondence. 5. May supervise the work of project coordinator and administrative staff. 6. Serves as liaison to other departments on all communications. 7. Contributes to design, organization, and maintenance of department website. 8. May perform other duties as assigned. Required Skill/ability 1: Previous experience working with FDA ,EMA regulated clinical trials, "Investigational new drug application", "Investigational device exceptions", and or "IRB Submission". An understanding of regulatory submission, regulatory communication, on-going management, and close-out requirements. Required Skill/ability 2: Knowledge of design and methods used in translational and clinical research. Required Skill/ability 3: Strong knowledge of federal and state regulations protecting human subjects involved in research, and demonstrated ability interpreting federal, state, University, and sponsor policies and regulations. Required Skill/ability 4: General technical knowledge of FDA and EMA clinical trial regulations (GCP) and regulations for use of investigational new drugs and devices. 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. Preferred Education: A Masters, PhD, PharmD or other advanced degree in a physical or natural science; work experience in medical/public health research, clinical trial coordination, medical writing, or IRB review. Work Week: Standard (M-F equal number of hours per day) Posting Position Title: Project Administrator University Job Title: YCCI IND/IDE Clinical Trials Project Manager Preferred Education, Experience and Skills: A Masters, PhD, PharmD or other advanced degree in a physical or natural science; work experience in medical/public health research, clinical trial coordination, medical writing, or IRB review. Bachelor's Degree in a related field and four years of related work experience or an equivalent combination of education and experience.

YCCI IND/IDE Clinical Trials Project Manager | Yale University - Military Veterans

at HERC - Metro New York & Southern Connecticut

New Haven, CT