Manager, Clinical Operations
About The Position
The Manager, Clinical Operations manages staff in accordance with organizational policies and applicable regulations, including overseeing work assignment, performance assessment, professional development, employee relations, and problem resolution. The role participates in hiring and onboarding, ensures staff have the resources and training needed for their responsibilities, and assigns staff to clinical studies according to their experience and training. The manager oversees the quality and workload of assigned staff through regular review, evaluation, and reporting. The position identifies quality risks and issues and develops corrective action plans. It may involve collaboration with clinical teams and functional leaders to address project challenges and deliver exemplary customer service, as well as participation in organizational quality and process-improvement initiatives.
Requirements
- Prior clinical trial experience, including experience in a management or leadership capacity, or an 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.
- Computer skills, including proficiency in Microsoft Word, Excel, and PowerPoint.
- Written and verbal communication skills, including a good command of English.
- Excellent organizational and problem-solving skills.
- Effective time-management skills and the ability to manage competing priorities.
- Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Nice To Haves
- Bachelor's degree in a scientific discipline or health care preferred.
Responsibilities
- Manage staff in accordance with organizational policies and applicable regulations, including planning, assigning, and directing work; assessing performance; guiding professional development; rewarding and disciplining employees; and addressing employee relations issues.
- Participate in hiring by reviewing candidates and interviewing; ensure new employees are onboarded and trained.
- Ensure staff have the materials, systems access, and training needed to perform their responsibilities; oversee training plans, SOP reviews, and training experiences as applicable.
- Participate in allocating resources to clinical research projects by assigning staff to studies based on 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 staff performance deficiencies.
- Regularly review and report findings to ensure staff meet defined workload and quality metrics.
- Collaborate as needed with clinical teams and functional leadership to manage project challenges and achieve exemplary customer service.
- Participate in corporate or organizational departmental quality or process-improvement initiatives.
Benefits
- Health and welfare benefits may be offered, depending on the position.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
