• Participates in setting timelines and commit to them or be able to negotiate schedule changes in response to project demands.
• Uses extensive knowledge of clinical listing reviews to create an optimal listing review format, per study and therapeutic area, to share with tea-----------mbers
• Collaborates with Growth Team Partners to ensure seamless functionality across multiple studies, while managing the individual studies from a metrics perspective and supporting their study leads
• Provides clinical review training to all CDM staff performing clinical review activities.
• Participates in the development and implementation of processes, procedures, and training for the data management function, as directed
• Mentor new staff
• Review patient data in accordance with GCP, SOPs/WPDs, and DVMs.
• Liaise with colleagues in other functional groups and management regarding data review activities for allocated studies.
• Read and understood project protocols and DVMs.
• Review patient data in accordance with the Clinical Listings Review Plan in the DVM.
• Identify data issues and work with PPD team to resolve.
• Ensure data accuracy according to departmental operating procedures.
• Ensure applicable data review activities are completed in a timely manner and meet quality expectations.
• Provide support for clinical data review to the CDM project team.
Verified
