Summary of Responsibilities:
- Based on forecast models, manage the resources to meet or exceed business Service Level Agreements.
- 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, 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, including initiative-taking prevention strategies based on metrics and forecasts.
- Assist with the quality management activities according to the Global data management Plans and Quality Management (QM) Plans and in process quality control activities to ensure staff deliver accurate, timely, consistent, and quality clinical data.
- Support locally based project staff on achieving client satisfaction (internal and external) 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 for user Account Management/Data Entry activities/ eTMF Documentation/ Decommissioning.
- Identify and implement process improvement solutions and ensure revenue and operating margin performance of the group to agreed targets.
- Create action plans to address staff quality and performance issues identified by clients, via client satisfaction surveys, and/or from core project team feedback.
- Manage utilization and billability of staff, planning for resource allocation, recruitment based on individual skills, competencies and availability and Provide support to Business Development for time and cost estimates.
- Ensure that staff reviews (performance review, training, and development, etc.) are completed for each member in accordance with Fortrea guidelines.
- All other duties as needed or assigned.
Qualifications (Minimum Required):
- B.Sc. degree in Life Science/Pharmacy or equivalent/related discipline or certification in a related allied health profession from an appropriately accredited institution (e.g., Nursing certification, Medical or Laboratory Technology) is preferred.
- In lieu of the above requirement, approximately 18 months of relevant experience in related field (pharmaceutical, laboratory, data analysis) incorporating approximately oneyear clinical data management experience in addition to the five-year relevant experience in User Account Management/Data Entry activities/ eTMF Documentation will be considered.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Broad knowledge of drug development process will be considered.
- 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 including international requirements for the conduct of clinical development programs especially as related to data handling and processing.
Experience (Minimum Required):
- Eight to ten (8-10) years of relevant work experience with two to four (2-4) years supervisory experience to include User Account Management/Data Entry activities/ eTMF Documentation/management and knowledge of several therapeutic areas.
- Demonstrated skill for management of staff of 10 to 15 employees within one location of a region (Asia Pac, Europe, North America, etc.).
- 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.
- Working knowledge of the relationship and regulatory obligation of the CRO industry with pharmaceutical/biotechnology companies.
- Demonstrated ability to lead local teams on business strategies and achievement of department goals, objectives, and initiatives and to encourage team members to seek solutions.
Physical Demands/Work Environment:
- Role is office-based, with associated risks of repetitive strain injury (associated with keyboard operation) and eye strain (associated with VDU screen operation).
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