Clinical Trials Project Manager
Apply NowCompany: Yale University
Location: Lakeville, CT 06039
Description:
Essential Duties
1. 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.
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.
Position Focus:
As Project Manager specializing in multi-center surgical clinical trials, this position is essential to the successful multi-center initiation, implementation, regulatory oversight, and close-out of investigator-initiated projects in surgical research. Specifically, the project manager will be responsible for a multi-center trial focused on harmonizing standards for reconstructive transplantation, funded by the Department of Defense and directed by the division chief of Plastic Surgery at Yale.
Generally, the Project Manager will support the sponsor level responsibilities for multi-center clinical trials. Serving as a surgical research subject matter expert, the Project Manager will streamline communication and operations between Yale Surgery faculty investigators, leadership, and participating site staff, funding agencies and other departments at Yale, as applicable. This role is critical to ensuring compliance with Federal regulations, maintaining integrity of study protocols involving human subjects, and facilitating cohesive communication across multiple sites and meeting milestones set by funding agencies. The role will have independent ownership of assigned projects, and responsibility for oversight of timelines and deliverables. Other duties as assigned.
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.
Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).
Required Skill/Ability 1:
Ability to manage time effectively and work independently and within a team to meet objectives. Strong attention to detail and demonstrated skill working with minimal supervision. Ability to focus on detailed information and perform tasks requiring precision.
Required Skill/Ability 2:
Ability to hold self and others accountable to achieve timebound results. Flexible approach and ability to adapt to shifting demands of evolving priorities. Focused on continuous process improvement and efficiency to optimize workflow.
Required Skill/Ability 3:
Demonstrated ability to provide proactive, flexible, and customer service focused communication and advice; work effectively with others; and demonstrate ethics and integrity in a professional matter, sensitivity to confidentiality, and a commitment to protecting research participants. Ability to communicate clearly and effectively, both verbally and in writing.
Required Skill/Ability 4:
Strong knowledge of Good Clinical Practice guidelines. Demonstrated experience interpreting federal, state, University policies and regulations. Demonstrated ability with interpreting complex clinical trial protocols and federal, state, local guidelines, and contracts.
1. 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.
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.
Position Focus:
As Project Manager specializing in multi-center surgical clinical trials, this position is essential to the successful multi-center initiation, implementation, regulatory oversight, and close-out of investigator-initiated projects in surgical research. Specifically, the project manager will be responsible for a multi-center trial focused on harmonizing standards for reconstructive transplantation, funded by the Department of Defense and directed by the division chief of Plastic Surgery at Yale.
Generally, the Project Manager will support the sponsor level responsibilities for multi-center clinical trials. Serving as a surgical research subject matter expert, the Project Manager will streamline communication and operations between Yale Surgery faculty investigators, leadership, and participating site staff, funding agencies and other departments at Yale, as applicable. This role is critical to ensuring compliance with Federal regulations, maintaining integrity of study protocols involving human subjects, and facilitating cohesive communication across multiple sites and meeting milestones set by funding agencies. The role will have independent ownership of assigned projects, and responsibility for oversight of timelines and deliverables. Other duties as assigned.
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.
Inquiries concerning Yale's Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).
Required Skill/Ability 1:
Ability to manage time effectively and work independently and within a team to meet objectives. Strong attention to detail and demonstrated skill working with minimal supervision. Ability to focus on detailed information and perform tasks requiring precision.
Required Skill/Ability 2:
Ability to hold self and others accountable to achieve timebound results. Flexible approach and ability to adapt to shifting demands of evolving priorities. Focused on continuous process improvement and efficiency to optimize workflow.
Required Skill/Ability 3:
Demonstrated ability to provide proactive, flexible, and customer service focused communication and advice; work effectively with others; and demonstrate ethics and integrity in a professional matter, sensitivity to confidentiality, and a commitment to protecting research participants. Ability to communicate clearly and effectively, both verbally and in writing.
Required Skill/Ability 4:
Strong knowledge of Good Clinical Practice guidelines. Demonstrated experience interpreting federal, state, University policies and regulations. Demonstrated ability with interpreting complex clinical trial protocols and federal, state, local guidelines, and contracts.