YCCI Senior Clinical Trials Project Manager
University Job Title
None - Not included in the union (Yale Union Group)
Administration & Operations
Compensation Grade Profile
Manager; Program Leader (P6)
Medical School Campus
2 Church Street South Doctor's Building
New Haven, CT 06519
Standard (M-F equal number of hours per day)
Searchable Job Family
Research Res Support
Total # of hours to be worked:
As an integral member of the multi-center clinical trials project management team for clinical research, the position ensures an environment that promotes quality research management and facilitates interdisciplinary research activities. The Sr. Clinical Trials Project Manager further promotes a compliant culture appropriate for a large physician organization with clinical affiliations across multiple academic and non-academic medical centers including coordinate initiatives which identify, prevent, and appropriately mitigate multisite trials and FDA Part 11 research system compliance risk, and ensure that YSM, YM, YNHH compliance efforts align with the university's broader compliance strategy and framework. The position coordinates effectively with other units/departments within the university such as biostats (YCAS), EHR research team (JDAT), Human Subjects Protections (HRPP), industry contracting team, and finance; clinical trials sponsors and vendors; and with research teams at other academic centers. Familiar with a variety of the field's concepts, practices, and procedures and relies on experience and judgment to plan and accomplish goals. This position may require remote work on either a regular or temporary, part-time or full-time basis.
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.
Required Education and Experience
Bachelor's Degree in a related field and five years of related work experience or equivalent combination of education and experience.
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 2:
Experience in clinical trial management for FDA regulated industry-sponsored clinical trials, or an equivalent combination of education and experience.
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.
Required Skill/Ability 4:
Comprehensive technical knowledge of FDA and EMA clinical trial regulations.
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.
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.
Preferred Licenses or Certifications:
Project Management Professional (PMP) certification.
Weekend Hours Required?
Evening Hours Required?
Background Check Requirements
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process.
Covid Vaccine Requirement
Please note that the university has a COVID vaccination requirement; visit for details. For up-to-date information visit COVID-19 website
The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.
Affirmative Action Statement:
Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual's sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the University's Title IX Coordinator, at TitleIX@yale.edu, or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: firstname.lastname@example.org.
Yale University is a tobacco-free campus
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Preferred Years Of Experience:5 Year(s)
Education Required:4 Year Degree - BS
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