Manager, Clinical Study Management
Celerion Switzerland AG
Date de publication :
08 novembre 2024Taux d'activité :
100%Type de contrat :
Durée indéterminée- Lieu de travail :Lincoln, NE
The Manager, Clinical Study Management is responsible for managing operational execution and study management components for clinical studies. Ensures protocol and regulatory compliance, as well as significant interaction.
\n
- Responsible for staff management in accordance with the organization’s policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning assigning and directing work; addressing complains and resolving problems; development and coaching employees.
- Plan, organize and facilitate workloads and schedules of staff to ensure that timelines are met and to ensure appropriate CSM coverage.
- Attend and participate in study specific meetings related to study set up, timeline and production of management, study status and data cleaning.
- Oversee data QC and DM functions required for on-time performance and compliance with regulatory and internal procedural requirements. May be required to carry out study tasks to support team workload.
- Participate in standard monitoring visits, site qualifications, regulatory inspections and sponsor audits as required.
- Monitor process efficiency and implement process improvement as needed, including identification of error trends and resolutions. Lead and/or participate in problem-solving for the clinical processes. Lead and/or participate in functions required to ensure success of the clinical operations.
- Bachelor’s degree in a related field required
- 1-2 years supervisory experience preferred
- Prior Clinical Study Manager experience preferred
- Ability to organize and manage multiple priorities required
- Excellent oral and written communication skills required
- Problem solving skills required
- Knowledge of Good Clinical Practices, Medical Terminology, ICH Guidelines and 21 CFR Part 11 preferred
\n