The Reader Manager is accountable for the day-to-day management of the Company’s external readers who provide a blinded independent central review of clinical trial data including images. This function is responsible for working with the Project Management and Scientific teams, as well as external Readers, to ensure that reviewers are identified and contracted to enable the effective execution of clinical studies.
Director of Global Services
RESPONSIBILITIES & ACCOUNTABILITIES
• Consistently performs duties within established 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).
• Provide management and oversight of Reader groups and individuals and ensure regulatory compliance.
• Work with the Sales and Finance teams to develop the Independent Read pricing structure.
• Identify and contract Readers for studies following Company SOPs
• Develop and maintain relationships with institutions and individual physicians to grow the Reader pool.
• Work with project teams to support high-demand projects including Reader resource planning and expedited read payment structure.
• Identify areas for process improvement in Reader selection and management.
• Oversight and management of periodic reader documentation assessments
• Manage Independent Reader database.
• Develop and maintain a database of reader performance.
• Develop and maintain Reader Management department KPI and metrics.
• Provide reports on reviewer usage and costs.
EDUCATION & EXPERIENCE
• Bachelor’s degree, in sciences/healthcare preferred.
• Min 5 yrs. Experience in Clinical research experience within a CRO or pharmaceutical company
• Broad spectrum disease area knowledge and knowledge of different Independent Reader types e.g. cardiology, radiology, nuclear medicine
• Good understanding of different contract types and required contract language including GDPR, HIPAA
• Excellent attention to detail, quality checks own work
• Good proficiency in Microsoft Office including Word and Excel spreadsheet creation, maintenance, and data analysis.
• Established network including radiology and nuclear medicine contacts.
• Strong project and time management skills
• Ability to adapt to changing priorities.
• Excellent verbal and written communication skills
• Strong organizational skills
• Strong networking skills
• Ability to travel to attend conferences