Dallas is growing! We are looking to hire an Operations Manager for our Phase I Clinic. In this role you will be responsible for management, administration, organization and conduct of the Study Operations department. You will also provide leadership, training, coaching and mentoring of clinical operation supervisors and staff.
Duties and Responsibilities:
- Directly or indirectly supervise clinical operations technical and professional staff.
- Ensure that all work is carried out in strict adherence with relevant protocols, SOP's, and in compliance with ICH/GCP guidelines. Ensure that Operations staff is trained and compliant with SOP's and Skills checks. Ensure that all training files are up to date and complete in accordance with SOPs and ICH/GCP.
- Ensure that the scientific and medical standards provided are met.
- Collaborate with Client Services with the development of client proposals.
- Lead client visits and interactions as appropriate.
- Initiates collaborative relationships with external institutions when protocol required.
- Initiates procurement of external resources, consultants, or equipment when protocol required.
- Develops strategies for efficient study conduct, data collection, subject management and safety monitoring. Coordinates efforts interdepartmentally to accomplish these strategies.
- Coordinates/collaborates P&L departmental strategy.
- Back up to Clinic Director as appropriate
- Champion/drive implementation of new company initiatives in terms of process improvement or new technology related to clinical research.
- Supports management in assuring professionalism and adherence to company principles of Customer Service.
- Assist with the development of Operation's department budget.
- Responsible for all aspects of project related matters in agreement with client and supervisory personnel.
- Performs other duties as assigned
- Overtime and weekend work as required.
- BS in science or medical field
- 8-10 years clinical research experience.
- At least 5-7 years of progressive and proven leadership responsibilities in a related business environment.
- Minimum of 5 years supervisory experience.
- Six Sigma Green Belt is preferred.
- Additional experience may be substituted for education requirements.
Apply on company website