Clinical Operations Director
2 days ago
Research & Development Institute, Inc. is a leading tech-enabled Contract Research Organization (CRO) that provides innovative solutions to In Vitro Diagnostic manufacturers. We are seeking a highly experienced Clinical Operations Director to join our team.
Job OverviewThe Clinical Operations Director will be responsible for managing a team of clinical staff working in support of clinical studies. This includes ensuring projects are appropriately resourced, employees are trained, and project objectives are met.
Key Responsibilities- Manage staff in accordance with policies and applicable regulations, including planning, assigning, and directing work, assessing performance, and guiding professional development.
- Participate in the selection process for hiring new employees, including conducting candidate reviews and participating in the interviewing process.
- Ensure staff has the necessary materials, systems access, and training to complete job responsibilities.
- Participate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and training.
- Manage the quality of assigned staff's clinical work through regular review and evaluation of work product.
- Identify quality risks and issues and create corrective action plans to prevent or correct deficiencies in performance of staff.
- Ensure staff are meeting defined workload and quality metrics through regular review and reporting of findings.
- Collaborate with other clinical teams and functional leadership to manage project-related challenges and achieve exemplary customer service.
- Prior clinical trial experience, including experience in a management/leadership capacity or equivalent combination of education, training, and experience.
- In-depth knowledge of applicable clinical research regulatory requirements, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
- Good leadership skills, including the ability to establish and maintain effective working relationships with coworkers, managers, and clients.
- Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
- Excellent written and verbal communication skills, including a good command of English.
- Effective time management skills and ability to manage competing priorities.
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