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Senior Program Manager

Charles R. Drew University
Los Angeles, CA Full Time
POSTED ON 1/7/2025 CLOSED ON 1/28/2025

What are the responsibilities and job description for the Senior Program Manager position at Charles R. Drew University?

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. The university leads multiple partnerships and programs to provide equitable healthcare resources in a variety of 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 participating 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 on-going 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 trails and provide strategy plans to the Center Director to identify and recruit sites to ensure the trails are conducting and staying on track.
  • Work with the site staff to ensure patient and site satisfaction. Ensure all relevant paperwork will be in full regulatory compliance, such as data management policies, budgeting, and the proper ethics approvals.
  • Provide clinical trial expertise and oversight to team.
  • Manage overall study timelines and oversight of the vendors deliverables.
  • Manage CROs and third-party vendors to ensure development and delivery of study documents, plans, and manuals.
  • Coordinate study supplies.
  • Responsible for oversight and management of individual studies as well as 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 and data.
  • Ensure publication of any findings or studies generated by researchers associated with the Center.
  • Monitor and maintain research study source documents for research study sponsors.
  • Monitors study subjects and coordinators for GCP compliance and adherence to protocols.
  • Monitors IRB and Sponsor/CRO correspondence.
  • Completion and correction of case report forms and source documents, either paper or electronic.
  • Recording and AE/SAE reporting.
  • Assuring compliance with FDA/GCP guidelines.
  • Develop and manage networks between an array of companies and organizations, including hospitals, pharmaceutical companies, government-based organizations, nongovernmental agencies, and clinical research organizations.
  • Maintains competency and keeps up with trends and changes in regulations and developments in clinical research, both internally and externally.
  • 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 is 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 is required.
  • Minimum Field of Expertise: Directly related professional and supervisory experience in program specialization.
  • Grant administration and operations experience is required.
  • Experience working with IRBs, CROs, and Pharmaceutical Sponsors.
  • 5 or more years of direct staff management experience, including recruitment and training is preferred.
  • Combined experience/education as substitute for minimum education.

KNOWLEDGE/ABILITY/SKILLS:  

  • Scientific understanding the trials and familiarity with the principles and processes of clinical trails.
  • Knowledge of clinical trials management systems (ctms) or other electronic medical record (emr) systems.
  • Knowledge of human subjects’ research as it pertains to recruitment of participants (navigating a protocol, eligibility criteria, schedule of events, procedures, study timelines, study design, background, and mechanism of action of ips, irb, recruitment materials, etc.)
  • Demonstrate understanding of clinical trials and enrollment procedures within gcp guidelines and hipaa requirements.
  • Knowledge of university irb policies and procedures as they apply to the submission and conduct of clinical research recruitment materials and methods.
  • Knowledge of medical terminology.
  • Ability to build strong professional relationships with diverse stakeholders, community, research teams, sponsors, regulatory authorities, and site personnel.
  • Bilingual (Spanish) - Spanish speaking preferred.
  • Ability to work independently.
  • Strong written and verbal communication abilities and highly effective interpersonal skills.
  • Ability and/or experience supervising and training employees, including organizing, prioritizing, and scheduling work assignments.
  • Ability and/or experience managing budgets, preferably research project budgets.
  • Ability to deliver feedback in an effective manner.
  • Ability to multitask, collaborate and prioritize.
  • Conflict resolution experience.
  • Ability and/or experience in developing and implementing research tools.
  • Ability and/or experience developing and presenting professional reports and presentations to senior-level audiences.
  • 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 while providing/obtaining information on numerous inquiries is paramount to success in this position.
  • Demonstrated competencies in strategic and systems thinking, project management, and knowledge of continuous improvement methods.
  • Ability to manage various projects and assignments with multiple priorities in a rapidly changing environment.
  • Must have strong interpersonal skills with demonstrated effectiveness in management and group dynamics, including team problem-solving skills.
  • Experience developing and communicating detailed, technical-scientific, and administrative program information to various audiences in written and oral form. Strongly prefer experience and knowledge in the Biological Sciences, Health, and Health Disparities.
  • Experience with Center development/expansion, including in scientific areas, student training, clinical research areas, and community-based areas, as well as related grant proposal development, writing, and submission to federal agencies or foundations.
  • Experience developing evaluation metrics to review the effectiveness of scientific, educational, and administrative program activities, recommending improvements, and assisting in executing recommendations.
  • Ability to develop and maintain professional working relationships in complex program/organizational settings involving heterogeneous constituents such as academic and clinical faculty, staff, students, and community partners from diverse backgrounds.
  • Experience interpreting operating policies, and procedures, resolving minor discipline and other employee relations issues within an academic setting or institution.

PHYSICAL DEMANDS:

  • The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Occasional stooping. Frequent standing.  Constant walking, sitting, climbing, reaching high/low levels, finger movement, feeling, speaking clearly, hearing conversationally, and seeing far and near.

WORK ENVIRONMENT:

  • Position is on site unless specific authorization from manager.
  • The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Occasionally required to work in confined space.

MENTAL DEMANDS:

  • The mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Frequent variety of unrelated tasks. Constant calculating, interrupted work, a variety of interrelated tasks, and use of sustained concentration, reasoning, judgment, resourcefulness, analytical ability, and ingenuity.

Special Requirements:

  • As a health professions institution of higher education, Charles R. Drew University of Medicine and Science seeks to protect the health and safety of the University community. As a condition of enrollment and employment, students, faculty, and staff must comply with the current CDU COVID-19 requirements as described on the CDU COVID-19 webpage.  Please visit the CDU Return to Campus website https://www.cdrewu.edu/covid-policy/ or email the Campus Nursing Office at nurseofficer@cdrewu.edu.
  • 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 of restricted funds or, the duration of a specific program, project, grant or contract. The duration of grant for this position is through June 30, 2025.

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 of Medicine and Science will consider qualified applicants, including those with criminal histories, in a manner consistent with state and local “Fair Chance” laws.

    Salary : $91,100 - $130,000

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