Description
We are seeking a Clinical Data Management Supervisor to oversee the management of clinical data for our clients.
Job Summary: As a Clinical Data Management Supervisor, you will be responsible for managing resources to meet or exceed business Service Level Agreements, supervising and mentoring staff, and overseeing various data management activities.
Responsibilities:
- Manage resources to meet or exceed business Service Level Agreements based on forecast models
- Supervise, mentor, evaluate, and aid in staff development, career development, people skills, and achievement of competency standards
- Oversee EDC User account activations, deactivations, and modifications, Data Entry activities, De Commissioning activities, and eTMF documentation tasks
- Maintain productivity and quality indicators for global staff and support recruitment of new potential candidates
- Participate in identification and implementation of solutions to local and regional data management issues and concerns
- Assist with quality management activities according to Global data management Plans and Quality Management (QM) Plans
- Support locally based project staff on achieving client satisfaction through delivery of quality data, on-time, and on-budget
- Assist with development and execution of training programs and ensure staff achievement of position competencies
- Support development of global, harmonized SOPs and specific quality processes and procedures
- Identify and implement process improvement solutions and ensure revenue and operating margin performance of the group
- Create action plans to address staff quality and performance issues
- Manage utilization and billability of staff, planning for resource allocation, recruitment, and providing support to Business Development
- Ensure that staff reviews are completed for each member in accordance with Fortrea guidelines
Qualifications:
- B.Sc. degree in Life Science/Pharmacy or equivalent/related discipline or certification in a related allied health profession
- Approximately 18 months of relevant experience in a related field, including one year of clinical data management experience and five years of relevant experience in User Account Management/Data Entry activities/eTMF Documentation
- Broad knowledge of drug development process
- Understanding of global clinical development budgets and relationship to productivity targets
- Knowledge of resource management system/processes
- Knowledge of time and cost estimate development and pricing strategies
- Thorough knowledge of ICH/GCP Guidelines
Experience:
- Eight to ten years of relevant work experience with two to four years of supervisory experience
- Demonstrated skill for management of staff of 10 to 15 employees
- Excellent oral and communication and strong presentation skills
- In-depth knowledge of clinical trial process and tracking of staff productivity metrics
- Demonstrated skill for mentoring and developing staff on technical and core competencies
Physical Demands/Work Environment:
- Role is office-based, with associated risks of repetitive strain injury and eye strain