Clinical Trials Project Manager
Apply NowCompany: Yale University
Location: New Haven, CT 06511
Description:
Essential Duties
1. Directs and leads the development, implementation, and management of clinical trials processes in compliance with SOPs and relevant regulations; liaise with Clinical Research Manager (CRM) to ensure successful clinical trials conduct.2. Identifies, tracks and analyzes barriers in current clinical trials processes, and recommends project management process improvements to the AD, Clinical Operations and broader CTO Leadership Team.3. Organizes and project manages multiple projects and clinical trials, across internal and external teams from start-up to close-out. Acts as an expert resource and the primary liaison between the site and internal/external stakeholders to ensure timely study launch, administrative study maintenance, and closeout in accordance with local, state, and federal regulations, as well as contractual obligations.4. Collaborates with CRM and Principal Investigator (PI) on assessment and implementation of oncology trials for the research team. Including identifying study activation timelines and metrics, resolving potential discrepancies and/or barriers to enrollment prior to study activation, assessing trial acuity for resourcing purposes, and project managing deliverables across teams to meet deadlines.5. Works closely with leadership, internal constituents, ancillary committees, External Sponsors, and Contract Research Organizations (CROs) to resolve site-level barriers to activation and improve protocol activation timelines.6. Designs, develops, and executes communication systems to ensure effective and transparent exchange of information between project stakeholders, including the sponsor, regulatory team,clinical research operations team, pre-award team, contracting team, and Clinical Research Support Laboratory (CRSL). Ensures potential risks and issues related to administrative management of clinical studies are identified, managed, and/or escalated as appropriate to AD Clinical Operations7. Effectively manages project budgets to ensure financial targets are met through regular reviews of costs and project resources.8. Coordinates site qualification and site initiation visits. May present information to sponsors and other key stakeholders.9. Responsible for evaluating and scoring protocols in a staffing acuity tool as part of study activation.10. Works closely with leadership, internal constituents, ancillary committees, Industry Sponsors, and Contract Research Organizations (CROs) to resolve site-level barriers to activation and improve protocol activation timelines.11. Determines and provides final approval for local study activation by ensuring all appropriate regulatory and institutional approvals are met, appropriately documented and communicated.12. Performs other duties as assigned.
Required Education and Experience
A Bachelor's degree in a relevant academic/scientific field and a minimum of four years of experience in clinical research or an equivalent combination of education or demonstrated experience.
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:
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 300 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 Care Centers, and trials are available within 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research, prevention, and patient care, as well as community outreach and education.
Working under the Assistant Director of Clinical Operations, the Clinical Trials Project Manager is responsible for collaborating with the Yale Cancer Center (YCC) Clinical Trials Office (CTO) Oncology Disease Group to coordinate, implement, and evaluate all administrative aspects of clinical trial conduct, including feasibility (to include clinical research support laboratory, workload, and study prioritization), protocol review, study initiation, study maintenance, activation, and closeout activities. In addition, the Clinical Trials Project Manager will play an integral role in facilitating a new approach for extending complex clinical trials to Yale Cancer Center's network locations, allowing for the delivery of novel therapies to a wider patient population.
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.
Required Skill/Ability 2:
Ability to hold self and others accountable in order 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.
Required Skill/Ability 4:
Knowledge of Good Clinical Practice guidelines. Demonstrated ability interpreting federal, state, local and sponsor policies and regulations.
Health Care Worker
This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working a healthcare setting who have the potential for direct or indirect exposure to patients, human research subjects or infectious materials including body substance, contaminated medical supplies, devices and equipment, surfaces, or air. HCW have specific health requirements that must be met prior to starting work, including MMR vaccine or immunity, varicella (chickenpox) vaccine or immunity, TB screening, COVID vaccine according to University policy, hepatitis B vaccine or immunity, and annual flu vaccination.
1. Directs and leads the development, implementation, and management of clinical trials processes in compliance with SOPs and relevant regulations; liaise with Clinical Research Manager (CRM) to ensure successful clinical trials conduct.2. Identifies, tracks and analyzes barriers in current clinical trials processes, and recommends project management process improvements to the AD, Clinical Operations and broader CTO Leadership Team.3. Organizes and project manages multiple projects and clinical trials, across internal and external teams from start-up to close-out. Acts as an expert resource and the primary liaison between the site and internal/external stakeholders to ensure timely study launch, administrative study maintenance, and closeout in accordance with local, state, and federal regulations, as well as contractual obligations.4. Collaborates with CRM and Principal Investigator (PI) on assessment and implementation of oncology trials for the research team. Including identifying study activation timelines and metrics, resolving potential discrepancies and/or barriers to enrollment prior to study activation, assessing trial acuity for resourcing purposes, and project managing deliverables across teams to meet deadlines.5. Works closely with leadership, internal constituents, ancillary committees, External Sponsors, and Contract Research Organizations (CROs) to resolve site-level barriers to activation and improve protocol activation timelines.6. Designs, develops, and executes communication systems to ensure effective and transparent exchange of information between project stakeholders, including the sponsor, regulatory team,clinical research operations team, pre-award team, contracting team, and Clinical Research Support Laboratory (CRSL). Ensures potential risks and issues related to administrative management of clinical studies are identified, managed, and/or escalated as appropriate to AD Clinical Operations7. Effectively manages project budgets to ensure financial targets are met through regular reviews of costs and project resources.8. Coordinates site qualification and site initiation visits. May present information to sponsors and other key stakeholders.9. Responsible for evaluating and scoring protocols in a staffing acuity tool as part of study activation.10. Works closely with leadership, internal constituents, ancillary committees, Industry Sponsors, and Contract Research Organizations (CROs) to resolve site-level barriers to activation and improve protocol activation timelines.11. Determines and provides final approval for local study activation by ensuring all appropriate regulatory and institutional approvals are met, appropriately documented and communicated.12. Performs other duties as assigned.
Required Education and Experience
A Bachelor's degree in a relevant academic/scientific field and a minimum of four years of experience in clinical research or an equivalent combination of education or demonstrated experience.
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:
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries, and trains the future leaders in cancer science and medicine. There are over 300 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 Care Centers, and trials are available within 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research, prevention, and patient care, as well as community outreach and education.
Working under the Assistant Director of Clinical Operations, the Clinical Trials Project Manager is responsible for collaborating with the Yale Cancer Center (YCC) Clinical Trials Office (CTO) Oncology Disease Group to coordinate, implement, and evaluate all administrative aspects of clinical trial conduct, including feasibility (to include clinical research support laboratory, workload, and study prioritization), protocol review, study initiation, study maintenance, activation, and closeout activities. In addition, the Clinical Trials Project Manager will play an integral role in facilitating a new approach for extending complex clinical trials to Yale Cancer Center's network locations, allowing for the delivery of novel therapies to a wider patient population.
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.
Required Skill/Ability 2:
Ability to hold self and others accountable in order 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.
Required Skill/Ability 4:
Knowledge of Good Clinical Practice guidelines. Demonstrated ability interpreting federal, state, local and sponsor policies and regulations.
Health Care Worker
This role is a healthcare worker position. Healthcare workers (HCW) are defined as university employees working a healthcare setting who have the potential for direct or indirect exposure to patients, human research subjects or infectious materials including body substance, contaminated medical supplies, devices and equipment, surfaces, or air. HCW have specific health requirements that must be met prior to starting work, including MMR vaccine or immunity, varicella (chickenpox) vaccine or immunity, TB screening, COVID vaccine according to University policy, hepatitis B vaccine or immunity, and annual flu vaccination.