Manager 4, Clinical Research

Position Focus :

The Cardiovascular Data Science (CarDS) Lab at Yale School of Medicine is seeking a highly motivated Senior Research Manager to join our dynamic team.

This role offers an exciting opportunity to manage projects leveraging healthcare data to enhance patient care. Reporting to the Principal Investigator, the Senior Research Manager will oversee various sponsored projects aimed at improving diagnosis and prediction of cardiovascular diseases using applications of artificial intelligence.

Key responsibilities include leading project execution, planning, organizing, coordinating, and managing all related activities.

The Senior Research Manager will work with staff and team members to coordinate the recruitment for large prospective multi-site studies, supervise research teams across multiple institutions and departments, track project deliverables, and proactively resolve issues to achieve goals.

Additionally, they will provide direct oversight of deliverables and staff performance, ensure compliance with regulatory requirements, manage IRB processes, and formulate, design, and implement protocols to achieve the research aims.

Effective communication skills are crucial, as the Senior Research Manager will serve as the liaison for communication between internal and external partners, organizing and leading regular meetings with leadership and multi-site study teams to foster collaboration with internal and external partners.

Project management responsibilities include leading and organizing all study activities, from planning to the final report, developing clinical trial strategies, timelines, and contingency plans, managing and onboarding research staff and trainees, monitoring progress, and coordinating clinical data management.

They will also conduct data quality reviews, provide training and supervision to research trainees, assist with manuscript development and dissemination, participate in strategic planning for the research team’s long-term success, and contribute to the development of future research projects while improving dissemination efforts to stakeholders.

The ideal candidate will have proven experience in managing large-scale, multi-site research projects, strong leadership and project management skills, excellent organizational and communication abilities, and experience with regulatory compliance and IRB processes.

The CarDS lab is a multidisciplinary group of junior faculty, postdoctoral trainees, and graduate and undergraduate students across Yale.

We collaborate with informatics, computer science, and statistics groups at Yale and several leading institutions nationally and internationally.

We have developed novel tools to measure and improve care quality using data from electronic health records and software solutions for the early diagnosis of cardiovascular disorders.

Our research offers unique collaborative opportunities with industry, health systems and health technology partners. For more information, please visit CarDS Lab.

Essential Duties

1. Manages and conducts recruitment and assessment study components of all clinical research studies. In conjunction with the PI, develops timelines and protocols.

2. Acts as project manager in studies involving multiple sites. Oversees quality and recruitment, and responsible for organizational planning for all sites.

3. Manages a team of research staff. 4. Develops protocols for sample collection and long term storage in biorepository in studies involving tissue collection.

5. Assists the PIs with budget preparation for grants, tracking of funds, and managing of subcontracts with participating sites.

6. Develops, implements procedures and data quality assurance standards and creates and maintains Manual of Operations for recruitment and assessment, and sample collection components of studies.

Prepares and adjusts recruitment and assessment study plans by designing strategies and analyzing relevant data. 7. Prepares IRB submissions, annual re-approvals, and requests for amendments for the Yale IRB as well as applications to other IRBs and governing institutions involved in the studies.

8. Participates in the design of conduct of study reports. Evaluates recruitment and assessment study progress on an ongoing basis.

9. Determines subject's eligibility and acceptability to clinical studies based on the study inclusion and exclusion criteria from screening assessments.

10. Obtains and interprets medical outcome data and clinical test results from other sources : hospitals, physicians' office, and death certificates.

11. Establishes and implements an adverse monitoring protocol if necessary. 12. Prepares educational seminars and material to enhance staff knowledge and awareness of the purpose and value of the study.

13. Organizes retention events, including dinner and luncheon meetings. 14. May perform other duties as assigned.

Required Education and Experience

Bachelor of Science in Nursing or related field and six years of related and demonstrated experience or an equivalent combination of education and demonstrated experience.

Required Skill / Ability 1 :

Demonstrated experience in the coordination and writing of federal grants.

Required Skill / Ability 2 :

Ability to work independently with minimal oversight, anticipate potential issues that may impact the research program and implement new policies or procedures when necessary.

Required Skill / Ability 3 :

Excellent communication skills, both written and verbal. Ability to produce high quality written work and track deliverables.

Must demonstrate excellent organizational skills, attention to detail, efficiency, and critical thinking.

Required Skill / Ability 4 :

Demonstrated experience in hiring, training, and supervising a research team. Ability to assess quality of data collection and provide actionable feedback and re-training when necessary.

Required Skill / Ability 5 :

Strong analytic skills, as demonstrated by developing and managing complex projects. Proficiency in Excel, Access, Word, and PowerPoint.

Preferred Education, Experience and Skills :

At least 10 years of demonstrated experience managing all aspects of federally funded clinical trials, including budgets, subcontracts, federal progress reporting, IRB submissions, subcontract development, Data Use Agreements, and Certificates of Confidentiality.

Weekend Hours Required?

Evening Hours Required?

Drug Screen

Health Screening

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.

EEO Statement :

University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans.

Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.