Director/Sr Director, Reading Center
They will work closely with the reading center technology partner to support continued evolution and optimize any cross functional collaboration ensuring adequate resource allocation. They will be responsible and accountable for internal reading center activities including but not limited to hiring and managing reader/graders, data quality management (review and adjudication process) and participating in the study-specific reading/grading process.
- Oversees the setting and optimization of Policies, Standard Operating Procedures, Work Instructions, and Study Specific Procedures in accordance with current GxP standards and applicable regulations (e.g., Good Clinical Practices, Good Documentation Practice, 21 CFR Part 11/Annex 11, MHRA, GDPR, HIPPA).
- Directs daily Reading Center operations, including staffing, scheduling, training, and performance evaluations as required
- Establishing and maintaining KPIs
- Proactively track ongoing study progress and deliverables
- Ensure projects are delivered on time and on budget
- Develop mitigation plans as needed
- Serve as a point of escalation for sponsors/clients
- Proactively assess processes and procedures for efficiency
- Collaborates with Clinical Operations, Quality Assurance and other departments to optimize delivery.Describe the specific responsibilities and job functions of the role
- Collaborates with marketing and sales to increase awareness of the offering and support business growth.
- Oversight and management of Vendors/service providers to the Reading Center
- Provides tactical support in reading/grading process and oversight as needed and as previous training and experience allows (not required but strongly preferred)
- Provides guidance to Lexitas stakeholders (internal and external) for future development trends.
- Work with Finance team to track forecasting and revenue estimations and optimize resource allocation.
- Develop and maintain relationships with institutions and individual physicians to grow the Reader pool.
- Oversight and management of periodic reader documentation assessments
- Develop and maintain Reader Management department KPI and metrics.
- Provide reports on reviewer usage and costs.
- Comprehensive understanding of scientific affairs and concerns in all stages of drug development
- A successful history of cross-functional collaboration
- Sound knowledge of all relevant regulations and guidelines
- Excellent verbal and written communication skills. Excellent presentation skills
- Good planning and organizational skills with the ability to adapt and adjust to changing priorities
- Ability to be productive and handle multiple tasks to meet deadlines in a dynamic, fast-paced environment
Lexitas Pharma Services, Inc., at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms.
Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.