|Title:||Manager, Clinical Data Management|
|Department:||Data Management and Biometrics|
|Job Status:||Full-time, Benefited|
Celerion, a global leader in clinical research, seeks an experienced client-facing data manager to join our Phoenix team! The Manager, Clinical Data Management is responsible for managing quality control and data coordination components for clinical studies and ensures regulatory compliance.
What that means in practice is that this role is an exceptional people-manager and trainer, accustomed to leading and managing a large functional team. This manager is also expected to be a savvy communicator, comfortable with client engagement and cross departmental collaboration. We seek a remarkable manager, who thrives balancing competing projects and priorities and takes great personal pride ensuring that our clinical data is accurate and flawless.
If you have experience managing data in clinical research, find your passion in scrubbing deviations from data sets, and genuinely enjoy managing and developing a team, we’d love to talk with you! Celerion is on the cutting edge of early stage pharmaceutical trials and continues to grow around the globe. We seek a strong department leader to contribute to that growth.
- Staff management, including: interviewing, hiring, and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems; development and coaching of employees.
- Communicate and provide support/guidance to ensure data QC and DM processes are followed to deliver quality product on-time with zero defects in compliance with regulatory requirements.
- Plan, organize and facilitate workloads and schedules of staff to ensure that timelines are met and to ensure appropriate DM coverage.
- Monitor process efficiency and implement process improvement as needed, including data flow and identification of error trends and resolutions. Lead and/or participate in problem-solving for the quality control, data collection, and additional data management processes. Lead and/or participate in functions required to ensure success of data management department.
- Attend and participate in study specific meetings related to study set up, timeline production and management, study status and data cleaning.
- Participate in regulatory inspections and meet with Sponsors as required.
- Bachelors degree in related field required.
- Prior data management work experience required.
- Professional work experience in a CRO or Pharmaceutical environment is preferred.
- 5+ years supervisory or trainer/leader experience required.
- Ability to organize and manage multiple priorities required.
- Excellent oral and written communication skills required.
- Excellent organizational skills required.
- Problem solving skills required.
- Knowledge of Good Clinical Data Management Practices, Medical Terminology, GCP, ICH Guidelines, and 21 CFR Part11 preferred.
EOE AA M/F/Vet/Disability