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Senior Clinical Trials Project Manager
3 months ago
Position Focus:
As an integral member of the YCCI Protocol Activation and Lifecycle Management (PALM) team, the position ensures an environment that promotes compliant and timely activation of clinical trials and facilitates interdisciplinary administrative research activities. The Sr. Clinical Trials Project Manager further promotes a compliant culture appropriate across multiple academic and non-academic collaborators including coordinating initiatives which identify, prevent, and appropriately mitigate project risk, and ensure that all projects are completed per targeted milestones and deliverables. The position collaborates and coordinates effectively with Principal Investigators and study teams, other units/departments within the university such, 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, the Senior Clinical Trials Project Manager relies on experience and judgment to plan and accomplish goals. This position requires remote work on either a regular or temporary, part-time or full-time basis.
A critical component of the role will be supporting the projects related to Yale’s work to ensure clinical trials are activated in a compliant and timely manner. As such, the incumbent must have a deep understanding of the administrative processes associated with activating a clinical trial and have exceptional project management and command skills. The incumbent must also have a willingness to work in partnership across a broad range of collaborators and the ability to work within a team environment to drive project deliverables.
Essential Duties
1. Reviews and determines staffing needs, job posting requirements, salary guidelines, and labor agreement interpretations for exempt and non-exempt staff in one or more functional department of the University. 2. Manages the administrative support needs for exempt and nonexempt staff and provides recommendations, improvements, solutions and assistance as needed. 3. Manages and monitors technology needs, conducts inventory, and system requirements for the assigned departments. 4. Develops and prepares budgets, financial forecasts, and financial analyses and the actual vs. budgeted performance reports for the departments. 5. Manages the use of facilities in one or more departments including office space, work stations, equipment, and office supplies. 6. Manages administrative support for activities of one or more departments to ensure timely completion of projects. 7. Manages and coordinates training sessions for assigned departments when new policies or practices are adopted. 8. Ensures compliance with University and federal regulations as they apply to the assigned departments. 9. Identifies, plans, and develops administrative policies for the assigned departments. 10. Assists in reviewing and implements University and departmental policies as they pertain to the administrative functions of the assigned department. 11. Assesses and makes recommendations regarding staff development and staffing levels. 12. Monitors, develops, plans, and executes systematic research on user requirements through such mechanisms as surveys, interviews, focus groups and competitive analysis. 13. Manages a staff of exempt and non-exempt employees. 14. May perform other duties as assigned.
Required Education and Experience
Bachelor’s Degree in related field and 5 years of experience or an equivalent combination of education and related experience.
Required Skill/Ability 1:
Extensive knowledge of federal and state regulations protecting human subjects involved in research, including comprehensive principals related to equitable access across all population with a specific understanding of research enablement in marginalized populations.
Required Skill/Ability 2:
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 startup/activation, external site feasibility, participant enrollment, on-going management of multiple external sites and protocols, study close-out, and regulatory submission.
Required Skill/Ability 3:
Comprehensive technical knowledge of FDA and EMA clinical trial regulations and guidance, including the implementation of related actionable strategies in practice.
Required Skill/Ability 4:
Ability to employ data analytics and project management tools for staff management, decision making and performance reporting of key performance metrics.
Required Skill/Ability 5:
Professionalism, 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. 10 years of clinical trials experience as a Project Manager for an industry Sponsor or CRO, working in diversity and equity space, strongly preferred. Experience in clinical management systems is preferred. Experience implementing innovative studies, involving technology and Electronic Health Record studies.
Preferred Licenses or Certifications:
Project Management Professional (PMP) certification.
Drug Screen
No
Health Screening
No
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. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.
COVID-19 Vaccine Requirement
The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
Posting Disclaimer
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.
