Senior Manager, Clinical Research Operations

Principal Duties and Essential Functions 

• Manages day-to-day operations and is responsible for administrative aspects related to the Research center in collaboration with faculty directors 

• Responsible for clinical trial processes and provides support to the clinical research team, and provides escalation to the Faculty Director when appropriate.

• Works closely with PIs and study staff to assess feasibility of undertaking new projects or proposed protocols

• Facilitates a protocol review committee 

• Establishes, develops and maintains partnerships with industry sponsors, other hospital collaborators and clinical trials network professionals as appropriate.

• Maintains collaborative, team relationships with peers and colleagues to effectively contribute to goals, and to help foster a positive work environment; may serve on Research and Hospital-wide committees related to clinical research and/or process improvement, if necessary or desired.

• Is responsible for the overall supervision of clinical research staff including hiring, training, performance reviews and termination. 

• Is responsible for accurate and timely submission of IRB documents, data submission to the Clinical Trial Management System (CTMS) and data collection requirements for study sponsors.

• Develops and monitors budgets, including standardized processes for budget development and budget workbook preparation and charge code identification. 

• Serves as primary contact for study monitor and on-site audits. Is responsible for ensuring appropriate preparation of materials for these activities.

• Ensures compliance with all hospital, local, state, federal and sponsor guidelines and regulations that govern clinical research. Liaises with Compliance Officer and Research Administration to uphold regulations and report non-compliance. Works effectively to create and fulfill corrective action plans as necessary.

• Works closely and communicates continuously with clinical research team and providers to steward effective recruitment, enrollment and retention processes.

• Ensures investigational drugs are handled appropriately and curates a positive working relationship with the Investigational Drug Service.

• Conducts regular team meetings, 1:1 staff meetings, and monthly meetings with leadership to review status of clinical trials, assess workloads, report on budget, and flag areas for discussion or decision-making  

• Ensures completion of each study on time and on budget and supervises the curating and logging of all study monitor and audit follow-up reports

• Works collaboratively with Research Administration to facilitate budgetary discussions related to funding, staffing, and financial projections.

• Promotes a responsive and customer-oriented team in the research center.

• Performs other similar and related duties as required or directed.

Job Knowledge and Skills

• Strong interpersonal and management skills to interact with academic faculty, clinicians, and staff

• Ability to manage and adhere to clinical research protocols, principles, and procedures

• Ability to develop and monitor clinical trials budgets

• Ability to engage in budget negotiation, financial auditing

• Understanding of clinical research methods such as screening, interviewing, reviewing medical records, case report forms, etc.

• Must possess strong planning, problem-solving, analytical, organizational, project management skills 

• Outstanding oral/written communication skills 

• Capacity to adaptively manage relationships with a variety of individuals in differing roles

• Ability to anticipate programmatic needs and flag project risks to faculty leadership 

• Ability to delegate to others by setting priorities for completing multiple tasks

• Proficient with the Microsoft Office Suite (Excel, PowerPoint, and Word) and Adobe Acrobat; familiarity with Box, Microsoft Teams, and Sharepoint a plus 

• Ability to effectively handle multiple competing deadlines and shifting priorities

• Keen analytical skills; ability to identify, gather, manage, and synthesize relevant information to support data-driven decisions

• Ability to have discretion with sensitive information, including PHI and other confidential information complying with institutional data privacy policies and guidelines