Director of Clinical Operations
Posted 1 month ago Expired
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Upload Your ResumeAbout This Role
This role manages study operational plans, project timelines, and the quality of deliverables. It involves planning, organizing, and overseeing daily clinical and administrative activities at a complex research site.
Responsibilities
- Manage study operational plans, project timelines, and quality of deliverables
- Plan, organize, and oversee daily clinical and administrative activities of a complex research site
- Develop, implement, and monitor programs, policies, and procedures to ensure participant and sponsor satisfaction
- Evaluate operational practices and provide recommendations
- Serve as an official company representative to sponsors, organizations, and governmental agencies
- Attend and conduct meetings to ensure proper execution of accepted protocols
- Supervise staff, overseeing performance evaluation and termination
- Oversee study enrollment and contract timelines
- Manage contracted studies efficiently
- Attend and participate in strategic and financial planning meetings
- Ensure all Sponsor visits are conducted in accordance with site policy
- Determine staffing needs and make Clinical Research Coordinator and Research Assistant assignments
- Interface with Sponsors/Investigators throughout agreements
- Ensure study records are maintained and protected
- Ensure all regulations are followed throughout study conduct
- Coordinate with appropriate departments to comply with internal and external audits
- Oversee processes related to controlled substances and DEA files
- Hire, train, supervise, and evaluate personnel, ensuring adherence to best practices, regulations, and SOPs
Requirements
- Minimum of 3-5 years experience in a leadership role in the clinical research industry
- Ability to understand company financials and strategic planning
- Experience in protocol development and training staff on protocol execution
- Experience in managing staff and implementing personnel procedures in a clinical research setting
- Strong verbal and written communication skills
Qualifications
- Bachelor's degree in related field or equivalent experience is preferred. Master’s Degree Preferred.
- Minimum of three to five years experience in a leadership role in the clinical research industry.
Benefits
About CenExel
CenExel is a network of research sites specializing in Phase I to Phase IV clinical trials, focusing on quality people, teamwork, and experienced clinical research managers.