Manager, Clinical Operations
Manager, Clinical Operations, IQVIA RDS Inc., Durham, North Carolina. Must telecommute (work from home) from anywhere in the U.S. and report electronically to the Durham, NC HQ site. Manage Clinical Operations staff in accordance with organization’s policies and applicable regulations. Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training. Plan, assign, and direct work, assessing performance, guiding professional development, rewarding and disciplining employees, addressing employee relations issues, and resolving problems. Participate in the selection for hiring new employees by conducting candidate review and participating in the interviewing process. Ensure that new employees are properly onboarded and trained. Ensure that staff has the proper materials, systems access and training to complete job responsibilities. Provide oversight for the execution of the training plan. Perform SOP review and training experiences, as applicable. Manage the quality of assigned staff's clinical work through regular review and evaluation of work product. Identify quality risks and issues and create appropriate corrective action plans to prevent or correct deficiencies in performance of staff. Ensure that staff are meeting defined workload and quality metrics through regular review and reporting of findings as outlined by clinical operations management. May collaborate with other clinical teams and other functional leadership to manage project-related challenges and to achieve exemplary customer service. Participate in corporate or organizational departmental quality or process improvement initiatives. Supervise 16-18 Clinical Research Associates and Senior Clinical Research Associates. Work M – F, 8 am – 5 pm and occasional time after hours for Regional/Global teleconferences.
Requires at least a Bachelor’s degree in Pharmaceutical sciences or scientific or health care discipline or related field or foreign equivalent. Requires three (3) years clinical operations experience to include three (3) years: applying Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines within clinical research; Microsoft Word, Excel and PowerPoint. Requires 30% domestic travel for Accompanied Site Visits with CRA’s or possible client meetings. Apply: send resume to grace.gibson@iqvia.com and reference job #111535.