Charles R. Drew University of Medicine and Science
Senior Program Manager
Charles R. Drew University of Medicine and Science, Los Angeles, California, United States, 90079
Mission Driven, Community Focused
About | Charles R. Drew University of Medicine and Science (cdrewu.edu)
Charles R. Drew University is located in the Watts-Willowbrook area of south Los Angeles and was founded in 1966 in the wake of the Watts uprising. CDU was founded to address inadequate medical care in the region and to provide equitable medical education opportunities for underrepresented students.
CDU is strongly invested in the local and regional community, leading multiple partnerships and programs to provide equitable healthcare resources in various south Los Angeles neighborhoods. Summary: Under the guidance of the PI and Supervisor, Dr. Jay Vadgama, we are seeking a highly motivated Senior Program Manager (SPM) to be a part of our team in the Center of Excellence in Clinical Research at Charles R. Drew University of Medicine and Science (CDU). This is a unique opportunity to join a multidisciplinary team dedicated to promoting minority participation in clinical trials. The SPM will provide team leadership and develop comprehensive plans for the initiation, execution, and completion of pharmaceutical clinical trials, from start to finish. This position is responsible for piloting new efforts, measuring and implementing successful strategies, tracking performance against specified goals and deadlines, and maintaining ongoing stewardship and communication with key external partners and internal stakeholders. Essential Duties and Responsibilities: Identify and/or recruit clinical sites (i.e., physicians) where necessary to implement multiple studies. Design and/or review protocols, budgets, CRFs, IRB protocols, SIVs, and any other documentation required to implement, manage the study, and deliver the required data to the sponsors. Evaluate pharmaceutical trials and provide strategy plans to the Center Director to ensure studies are conducted and stay on track. Work with site staff to ensure patient and site satisfaction, ensuring all relevant paperwork is in full regulatory compliance. Provide clinical trial expertise and oversight to the team. Manage overall study timelines and oversight of vendor deliverables. Manage CROs and third-party vendors to ensure development and delivery of study documents, plans, and manuals. Coordinate study supplies. Oversee individual studies and relevant program-related activities with minimal supervision, including managing team meetings (Agendas, Minutes, Action Items, Follow Up). Ensure studies are closed out in accordance with Good Clinical Practice. Ensure publication of findings or studies generated by researchers associated with the Center. Monitor and maintain research study source documents for sponsors. Monitor study subjects and coordinators for GCP compliance and adherence to protocols. Monitor IRB and Sponsor/CRO correspondence. Complete and correct case report forms and source documents, either paper or electronic. Record and report AEs/SAEs. Assure compliance with FDA/GCP guidelines. Develop and manage networks with various organizations, including hospitals, pharmaceutical companies, and clinical research organizations. Maintain competency and keep up with trends and changes in regulations and developments in clinical research. Engage with Community Engagement recruitment activities (includes health fairs, seminars, conferences, etc.). Other Duties and Responsibilities: Other duties as requested. EDUCATION: Bachelor's Degree Required - biomedical science related degree preferred. Master’s Degree Preferred. Clinical Trial Professional certification from a professional society within one year in position. EXPERIENCE: 3 or more years’ experience managing clinical trials, research programs, data management, and computer/related systems required. Directly related professional and supervisory experience in program specialization required. Grant administration and operations experience required. Experience working with IRBs, CROs, and Pharmaceutical Sponsors. 5 or more years of direct staff management experience preferred. Combined experience/education as a substitute for minimum education. KNOWLEDGE/ABILITY/SKILLS: Scientific understanding of trials and familiarity with clinical trial principles and processes. Knowledge of clinical trials management systems (CTMS) or other electronic medical record (EMR) systems. Knowledge of human subjects’ research as it pertains to participant recruitment. Understanding of clinical trials and enrollment procedures within GCP guidelines and HIPAA requirements. Knowledge of university IRB policies and procedures. Knowledge of medical terminology. Ability to build strong professional relationships with diverse stakeholders. Bilingual (Spanish) preferred. Ability to work independently. Strong written and verbal communication abilities. Ability to supervise and train employees, including organizing and prioritizing work assignments. Ability to manage research project budgets. Ability to deliver feedback effectively. Ability to multitask, collaborate, and prioritize. Conflict resolution experience. Experience in developing and implementing research tools. Experience in developing and presenting professional reports and presentations. Ability to work on weekends. Proficient in Microsoft Excel, Word, and PowerPoint. COMPLEXITY: The ability to perform highly detailed work with sustained attention and care is paramount to success in this position. Demonstrated competencies in strategic thinking, project management, and continuous improvement methods. Ability to manage various projects and assignments with multiple priorities in a rapidly changing environment. Strong interpersonal skills with demonstrated effectiveness in management and group dynamics. Experience developing and communicating detailed, technical, and administrative program information. Experience with Center development/expansion and grant proposal development. Experience developing evaluation metrics to review program effectiveness. Ability to develop and maintain professional working relationships in complex settings. Experience interpreting operating policies and resolving employee relations issues. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Occasional stooping; frequent standing; constant walking, sitting, climbing, reaching, finger movement, speaking, hearing, and seeing. WORK ENVIRONMENT: Position is on-site unless specific authorization from the manager. Occasionally required to work in confined spaces. MENTAL DEMANDS: The mental demands described here are representative of those that must be met to successfully perform the essential functions of this job. Frequent variety of unrelated tasks; constant calculating and sustained concentration. Special Requirements: As a health professions institution, Charles R. Drew University seeks to protect the health and safety of the community. Compliance with current CDU COVID-19 requirements is mandatory. Ability to work effectively with a diverse community, including persons of color and sexual minorities. Compensation: $91,100 - $130,000 Position Status: Full Time Work Location: On-site Conditional Statement:
The employment status of this position is classified as “Conditional”. Conditional employment means that the job exists contingent upon funding limitations or the duration of a specific program, project, grant, or contract. EEO Statement:
Charles R. Drew University is committed to Equal Employment Opportunity. Applicants will be considered without regard to gender, race, age, color, religion, national origin, sexual orientation, genetic information, marital status, disability, or covered veteran status. Fair Chance Statement:
Charles R. Drew University will consider qualified applicants, including those with criminal histories, in a manner consistent with state and local “Fair Chance” laws.
#J-18808-Ljbffr
CDU is strongly invested in the local and regional community, leading multiple partnerships and programs to provide equitable healthcare resources in various south Los Angeles neighborhoods. Summary: Under the guidance of the PI and Supervisor, Dr. Jay Vadgama, we are seeking a highly motivated Senior Program Manager (SPM) to be a part of our team in the Center of Excellence in Clinical Research at Charles R. Drew University of Medicine and Science (CDU). This is a unique opportunity to join a multidisciplinary team dedicated to promoting minority participation in clinical trials. The SPM will provide team leadership and develop comprehensive plans for the initiation, execution, and completion of pharmaceutical clinical trials, from start to finish. This position is responsible for piloting new efforts, measuring and implementing successful strategies, tracking performance against specified goals and deadlines, and maintaining ongoing stewardship and communication with key external partners and internal stakeholders. Essential Duties and Responsibilities: Identify and/or recruit clinical sites (i.e., physicians) where necessary to implement multiple studies. Design and/or review protocols, budgets, CRFs, IRB protocols, SIVs, and any other documentation required to implement, manage the study, and deliver the required data to the sponsors. Evaluate pharmaceutical trials and provide strategy plans to the Center Director to ensure studies are conducted and stay on track. Work with site staff to ensure patient and site satisfaction, ensuring all relevant paperwork is in full regulatory compliance. Provide clinical trial expertise and oversight to the team. Manage overall study timelines and oversight of vendor deliverables. Manage CROs and third-party vendors to ensure development and delivery of study documents, plans, and manuals. Coordinate study supplies. Oversee individual studies and relevant program-related activities with minimal supervision, including managing team meetings (Agendas, Minutes, Action Items, Follow Up). Ensure studies are closed out in accordance with Good Clinical Practice. Ensure publication of findings or studies generated by researchers associated with the Center. Monitor and maintain research study source documents for sponsors. Monitor study subjects and coordinators for GCP compliance and adherence to protocols. Monitor IRB and Sponsor/CRO correspondence. Complete and correct case report forms and source documents, either paper or electronic. Record and report AEs/SAEs. Assure compliance with FDA/GCP guidelines. Develop and manage networks with various organizations, including hospitals, pharmaceutical companies, and clinical research organizations. Maintain competency and keep up with trends and changes in regulations and developments in clinical research. Engage with Community Engagement recruitment activities (includes health fairs, seminars, conferences, etc.). Other Duties and Responsibilities: Other duties as requested. EDUCATION: Bachelor's Degree Required - biomedical science related degree preferred. Master’s Degree Preferred. Clinical Trial Professional certification from a professional society within one year in position. EXPERIENCE: 3 or more years’ experience managing clinical trials, research programs, data management, and computer/related systems required. Directly related professional and supervisory experience in program specialization required. Grant administration and operations experience required. Experience working with IRBs, CROs, and Pharmaceutical Sponsors. 5 or more years of direct staff management experience preferred. Combined experience/education as a substitute for minimum education. KNOWLEDGE/ABILITY/SKILLS: Scientific understanding of trials and familiarity with clinical trial principles and processes. Knowledge of clinical trials management systems (CTMS) or other electronic medical record (EMR) systems. Knowledge of human subjects’ research as it pertains to participant recruitment. Understanding of clinical trials and enrollment procedures within GCP guidelines and HIPAA requirements. Knowledge of university IRB policies and procedures. Knowledge of medical terminology. Ability to build strong professional relationships with diverse stakeholders. Bilingual (Spanish) preferred. Ability to work independently. Strong written and verbal communication abilities. Ability to supervise and train employees, including organizing and prioritizing work assignments. Ability to manage research project budgets. Ability to deliver feedback effectively. Ability to multitask, collaborate, and prioritize. Conflict resolution experience. Experience in developing and implementing research tools. Experience in developing and presenting professional reports and presentations. Ability to work on weekends. Proficient in Microsoft Excel, Word, and PowerPoint. COMPLEXITY: The ability to perform highly detailed work with sustained attention and care is paramount to success in this position. Demonstrated competencies in strategic thinking, project management, and continuous improvement methods. Ability to manage various projects and assignments with multiple priorities in a rapidly changing environment. Strong interpersonal skills with demonstrated effectiveness in management and group dynamics. Experience developing and communicating detailed, technical, and administrative program information. Experience with Center development/expansion and grant proposal development. Experience developing evaluation metrics to review program effectiveness. Ability to develop and maintain professional working relationships in complex settings. Experience interpreting operating policies and resolving employee relations issues. PHYSICAL DEMANDS: The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Occasional stooping; frequent standing; constant walking, sitting, climbing, reaching, finger movement, speaking, hearing, and seeing. WORK ENVIRONMENT: Position is on-site unless specific authorization from the manager. Occasionally required to work in confined spaces. MENTAL DEMANDS: The mental demands described here are representative of those that must be met to successfully perform the essential functions of this job. Frequent variety of unrelated tasks; constant calculating and sustained concentration. Special Requirements: As a health professions institution, Charles R. Drew University seeks to protect the health and safety of the community. Compliance with current CDU COVID-19 requirements is mandatory. Ability to work effectively with a diverse community, including persons of color and sexual minorities. Compensation: $91,100 - $130,000 Position Status: Full Time Work Location: On-site Conditional Statement:
The employment status of this position is classified as “Conditional”. Conditional employment means that the job exists contingent upon funding limitations or the duration of a specific program, project, grant, or contract. EEO Statement:
Charles R. Drew University is committed to Equal Employment Opportunity. Applicants will be considered without regard to gender, race, age, color, religion, national origin, sexual orientation, genetic information, marital status, disability, or covered veteran status. Fair Chance Statement:
Charles R. Drew University will consider qualified applicants, including those with criminal histories, in a manner consistent with state and local “Fair Chance” laws.
#J-18808-Ljbffr