Senior Program Manager

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 t