Operations Manager RSM2 Surgery Clinical Trials Office (CTO)
CTO Operations Managers Oversee the Operational Function of the CTO including daily oversight of the following areas: 1.Project Management 2.Regulatory 3.Protocol Development 4.Data Management 5.CTO Administration
Organizational Leadership Responsibilities (50%) Oversees the day-to-day responsibilities of CTO staff to ensure tasks/needs involving CTO staff are being met promptly. Directly oversees following staff: ?(3) FTEs: Research Support Managers who manage a clinical trial portfolio for Department of Surgery. This includes oversight of all projects, grants submissions, assist with staff & faculty development, and provide resources for all department personnel for research endeavors. FTE: Oversee Research Clinical Trial Specialist with all pre and post award effort in managing clinical trial budget oversight and development.
?Manage all staff in accordance with organization?s policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding, motivating and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters, including salary administration. ?Independently handles personnel issues, conflict management, defines goals that increase knowledge and skills of staff, and defines staff expectations ?Undertake business development activities and monitors growth and performance. Oversees the development of project timelines, maintain deliverables ?Increase the effectiveness and efficiency of Support Services through improvements to each function (Program & Project Management, Regulatory, Data Management, Protocol Development, CTO Administration) as well as coordination and communication between functions. ?Drive initiatives in the management team and organizationally that contribute to long-term operational excellence. ?Contribute to short and long-term organizational planning and strategy as a member of the management team ?Function as an advisor to staff members to meet expectations or resolve operational problems ?Frequent in contact with internal personnel at various management levels concerning projects, operational decisions, or requirements ?Exert influence in the development of overall objectives and long-range goals of the organization. ?Liaison between departments to ensure limited communication failures and smooth work transitions.
Work under Director of Research Operations in Department of Surgery, Research Support Services. Manage and provide leadership to Project Management personnel that will require facilitating successful interactions with key functional groups that include Clinical Teams, Data Management, MHealth, FRA, UMP, CTSI, Financial Hub, PIs, Quality Assurance and Trial Sponsors when necessary. (30%) ?Drive project management process improvement across department for clinical trial management. ?Perform risk analysis and manage outcome as appropriate for the project management team. ?Acts as a mentor for staff and guides areas of personal growth and improvement that leads towards professional advancement. ?Assist Research Director with issues that arise that could potentially stymie or lengthen the timelines of trials stages. ?Undertake business development activities and monitor growth and performance. ?Drive regulatory process improvement across CTO for clinical trial management. Oversees the development of regulatory project timelines, maintain deliverables and adherence to policies and procedures. ?Develop and implement regulatory risk analysis and management for the regulatory work being done in the department. ?Work in conjunction with the Leadership to develop a training program for new and incumbent staff. ?Drive data management process improvement across CTO for clinical trial management. Oversees the development of Data project timelines, maintain deliverables and adherence to policies and procedures
Partner with the Director of the Research Operations to ensure a quality service organization: (20%) ?Ensure that the SCTO is fully aligned and integrated with Surgery Research Support Services and Department of Surgery vision, goals and initiatives Efficient utilization of resources ?Streamline start-up phase of all Clinical trials (Budget and contracting, regulatory approval, data management and calendar building) ?Maintenance and management of CTO budget ?Ongoing training requirements of staff are met ?Ensures reporting requirements are met. ?Analyze and collect data regarding the operations of the CTO on a daily basis to maintain an efficient and productive model. Work with Department of Surgery Business Analysts to develop, improve and utilize key departmental metrics and metrics reporting to measure the effectiveness of departmental initiatives ?Work as a liaison between staff and Director to reduce the need of ?Director? involvement in minor issues that would take up valuable time better used for department oversight. ?Communicates major issues to Director in weekly meeting
BA/BS with at least 8 years of clinical trials related experience, or
Advanced degree with 6 years of clinical trials related experience
Experience providing oversight of a small division or cross-disciplinary team
In-depth knowledge of all aspects of clinical trials operations management
Ability to manage high volume of clinical trial studies
Excellent communication and organizational skills
Experience with medical device/surgical clinical trials
Experience in higher education/academic health centers
Experience working in a highly matrixed organization
Working knowledge of policies and procedures pertaining to clinical trials, human resource management, finance, etc at the University of Minnesota
Internal Number: 330598
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