|Title:||Manager, Clinical Data Management|
|Department:||Data Management and Biometrics|
|Job Status:||Full Time|
Join a team that's going places!
Every member of Celerion is involved in making a distinctive contribution to the health and well-being of people around the world. That's the sense of purpose shared by our employees. We are a performance-driven drug research company, operating in robust and growing markets. We have an exciting future and offer a strong development environment for our great employees.
Are you looking for an opportunity that will make a difference in the future of healthcare? The Manager, Clinical Data Management may be the position for you. Do you want to learn more?
This position will work out of our Lincoln, NE offices.
This position is responsible for leading quality control and data coordination components for studies and ensures regulatory compliance. Responsible for management of approximately ten team members in accordance with the organization's procedures/policies and all applicable regulations/laws. This will include interviewing, hiring, and training employees; planning, assigning, performing and directing work; appraising performance; rewarding and coaching employees; addressing concerns and resolving problems; development and mentoring of employees. Additionally, in this position you will provide technical and regulatory direction to appropriate groups/staff to ensure processes are followed and that quality on-time/zero defect standards are realized. You will also participate in regulatory inspections, meet with Sponsors as required and actively drive continuous process improvement.
- You will have a Bachelor’s Degree in a related discipline, a minimum of 5 years industry experience and a minimum of 2 years supervisory experience required.
- Your Certified Clinical Data Manager (CCDM) is helpful.
- Proven ability to organize and handle multiple priorities.
- Demonstrated oral and written interpersonal communication skills.
- High-level of initiative and ability to problem solve required.
- Knowledge of Good Clinical Data Management Practices, EDC, Medical Terminology, GCP, ICH Guidelines and 21 CFR Part 11 preferred.
A dynamic, groundbreaking and team oriented work environment and a comprehensive benefit package.
Are you ready to join our team?
EOE AA M/F/Vet/Disability