Manager of Clinical Research Operations

The Radiology Department is looking for a collaborative Clinical Research Operations leader with strong regulatory expertise and demonstrated success in developing and improving clinical research processes. The ideal candidate understands the full clinical research lifecycle, can translate regulatory and institutional requirements into practical workflows and SOPs, and is comfortable coaching a growing team through operational change. Experience supporting radiology or imaging-related research is strongly preferred.

The individual should be a team-oriented problem solver who can build relationships across clinical, regulatory, technical, faculty, and administrative stakeholders while establishing clear, scalable processes for the department

The Manager of Clinical Research Operations is responsible for providing overall coordination and management of workflow of the clinical research efforts e. Ensures that all internal and external regulatory agency policies, procedures, practices, and law are adhered to by all clinical research personnel.

• Assist in development and management of clinical research protocols for multiple disease teams in compliance with regulatory requirements (e.g., data collection and reporting, record maintenance and communication, protocol issue resolution, IRB engagement).
• Participate in set-up, planning, maintenance, and close-out of both single and multi-institutional national and international clinical trials.
• Track and oversee documentation, study status and key milestones within CTMS, eTMF, and other systems and applications as needed.
• Utilize tools, metrics, and reports as part of the full study management lifecycle.
• Serve in an advisory role for development of institutional and NIH (National Institutes of Health) grants.
• Act as a liaison between the Principal Investigators (study teams), internal bodies (e.g., CTO, CTSRC, IRB), and external bodies (e.g., FDA, NIH, pharmaceutical firms).
• Develop, implement, and maintain standard operating procedures and business processes for conduct of clinical protocols.
• Mentor and guide team members and ensure timely resource availability for accomplishment of outcomes.
• Track resource allocations and act as an escalation point for both study and staff-related issues.
• Engage in hiring, performance management, and other people processes.
• Perform other duties as assigned to meet the goals and objectives of the department and institution.
• Maintains regular and predictable attendance.

Bachelor's degree in relevant area required.

• Minimum Requirement: 6+ progressive years of experience in a relevant comparable clinical research operations area including experience managing at least 1-2 people preferred.
• Experience working with Cl. Res. Ops. systems/processes and their maintenance/implementation, as applicable to own area.
• Significant technical experience in area (e.g., research monitoring, regulatory documentation, etc.).
• Significant experience working with relevant regulations and guidelines (e.g., Good Clinical Practice Guidelines, Office of Human Research Protections review and reporting requirements), and supporting institutional compliance.
• Extensive experience leading projects/processes end to end including resource planning and management, and communication and collaboration with internal cross-functional teams and external partners preferred.
• Proven performance in earlier role.

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• Ability to think critically, draw insights and connect the dots. Openness to change and adapting to changing times with resilience and flexibility.
• Demonstrates strong knowledge/skills within area on a consistent basis to solve complex problems independently
• Able to draw insights from different sets of data and quickly understand why issues are happening. Solves problems quickly by identifying the root causes. Encourages others to see the opportunities ahead amidst changing circumstances even when the details have not been finalized.
• Skills in communicating complex ideas effectively to diverse audiences and influence others to see different points of view.
• Leverages advanced knowledge/ skills within area to identify and implement new/improved processes/approaches
• Can present/facilitate independently in senior-level meetings. Presents information as a…