Manager Clinical Research

Benefits

Qualifications

• •Minimum of 7 years of clinical research experience; at least 5 years of management or supervision of clinical trials; and at least 5 years of experience in clinical research finance
• •Demonstrated experience managing data collection, reporting, outcomes, and quality improvement; familiarity with standards/pathways
• •Knowledge and experience meeting FDA (GCP, ICH) guidelines and other applicable federal, state and local regulations concerning human research and gene therapy
• •Experience working with pharmaceutical companies and FDA agency representatives
• •1 more items(s)

Responsibilities

• •Under the supervision of the Director, this manager is responsible for establishing and assuring implementation of the strategic vision, directions, and day-to-day operations of the clinical research finance department
• •The role combines financial oversight of clinical research activities (budgeting, reporting, compliance) with staff leadership and coordination with sponsors and regulatory agencies
• •The position emphasizes regulatory compliance (including FDA GCP/ICH guidelines), data reporting, quality improvement, and partnership with pharmaceutical and agency representatives
• •Ensure the strategic vision, directions, and operations of the clinical research finance department are implemented and adhered to by all staff
• •Oversee clinical research finance activities including budgeting, financial management, reporting, and audit readiness
• •Manage data collection, reporting, outcomes tracking, quality improvement initiatives, and standards/pathways related to clinical research finance
• •Ensure compliance with FDA (GCP, ICH guidelines) and other federal, state and local regulations relevant to human research and gene therapy practices
• •Serve as a point of contact and collaborate with pharmaceutical sponsors and FDA agency representatives
• •Provide management and supervision of staff involved in clinical trials operations and finance, including training, oversight, and performance management
• •The role reports to a Director and requires coordination across Providence medical groups and affiliated practices
• •7 more items(s)