Clinical Laboratory Operations Manager
Battelle is guided by a founding mission. We invest our knowledge, talents and resources, helping our customers achieve their most important goals. We apply scientific rigor and creativity, succeeding where others may fail and we invest in our communities, making the world better for generations to come. All of us share a common purpose: to solve the greatest challenges of today and tomorrow.
Our 22,000 employees work at the forefront of scientific innovation to tackle critical challenges in security, human health, manufacturing, energy and environmental management. Battelle’s work is grounded in the belief that science, technology and a passion for excellence can make industries more competitive and the world a better place.
We are currently seeking a Registered Nurse with experience in laboratory-based clinical studies to serve as the Clinical Laboratory Operations Manager of our research facility in Baltimore, Maryland.
We are seeking a well-organized, detail-oriented, dependable team player to join our clinical staff as a Registered Nurse/Laboratory Operations Manager. This position will provide oversight for our day-to-day clinical laboratory activities and will be responsible for reporting to management on laboratory safety, adherence to protocols, financial standing, clinical staff training, and other related tasks. In this role you will work as part of multi-disciplinary team to oversee the study related activities that take place in the clinical research laboratory, review data collection efforts for quality, and work with study management teams to deliver high-quality technical data and documents for inclusion in client reports. The job supports a deadline-driven environment and we are seeking an individual who is used to working within tight time frames while still maintaining high-quality work.
Principal responsibilities are to:
- Manage on-site day-to-day clinical laboratory operations, oversee facility maintenance, and ensure that the facility operates within established budgets.
- Coordinate with MDs, Laboratory Technicians, and Research Associates to oversee implementation of research protocols and recruitment; keep Project Managers apprised of study progress
- Provide recommendations to upper management with respect to daily operations, lab staff training status, and compliance with study protocols and Battelle policies and procedures.
- Be an active working supervisor by helping plan, develop, schedule, and execute laboratory activities of studies within time and within budget.
- In conjunction with management, develop new and expanded core capabilities by identifying needs for specialized facilities, staff, and equipment to support technical areas and assisting management planning to meet these needs.
- Develop and maintain SOPs, methods, plans, and procedures.
- Ensure staff compliance with trainings and SOPs to ensure all client expectations are met.
- Perform data accuracy and/or technical monitoring of data collection, and collaborates with the PI to respond to any audit findings and implement approved recommendations.
- Maintain study files by ensuring documentation has been reviewed for technical content and data accuracy.
- Maintain/oversee flow of reports between various support groups, the Quality Assurance group, and study management team.
- Ensure staff are compliant with all relevant regulatory requirements (i.e., Good Clinical Practice Guidelines)
THE FOLLOWING REQUIREMENTS MUST BE MET TO BE CONSIDERED FOR THIS POSITION:
- Bachelors of Science degree in Nursing,
- Minimum of 5 years applicable work experience in a clinical research environment.
- Must be detail oriented, good communicator, used to working in a team environment, yet able to work independently; and must have the ability to work in a fast-paced, deadline-driven environment while maintaining high-quality work.
- Experience in working with study management on multiple projects simultaneously.
- Experience in Quality Assurance activities associated with Good Clinical Practices (GCP) in support of clinical studies.
- Good oral and written communication skills and must possess effective English language and grammar skills.
Battelle’s competitive benefits program includes comprehensive medical and dental care, matching 401K, paid time off, flexible spending accounts, disability coverage, and other benefits that help provide financial protection for you and your family.
Battelle provides employment and opportunities for advancement, compensation, training, and growth according to individual merit, without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, marital status, age, genetic information, disability, military or veteran status, or any other protected classes covered under federal or applicable state and local law. Our goal is for each staff member to have the opportunity to grow to the limits of their abilities and to achieve personal and organizational objectives. We will support positive programs for equal treatment of all staff and full utilization of all qualified employees at all levels within Battelle.
For more information about our other openings, please visit www.battelle.org/careers