Purpose
To build all necessary data/information needed in preparing internal documents/scientific reports related to clinical trials and; to keep multiple reports moving forward simultaneously through multi-tasking.
Responsibilities
- Prepare scientific reports and presentations related to clinical trials using available software and templates.
- Assists in constructing phase 1 clinical study planning documents, and writes Phase 1 protocols.
- Review clinical protocols and key decisions impacting project timelines with management.
- Comply with procedures set forth in relevant IQS documents and Study protocols and other directives issued by the management regarding clinical/ preclinical studies.
- Apply experience to analyze clinical study data, including statistical data using available software to assist with ongoing blinded efficacy and safety reviews and ensure the scientific integrity of all processes.
- Responsible for receiving and completing tasks and assignments from Therapeutic Area MD or Scientific Staff within timeline with minimal supervision
- Ensure scientific integrity of all processes by applying current electronic document conventions and processes consistently and accurately.
- Integrate clinical trial data across studies and identify issues impacting projects and provide this information to internal peers and therapeutic area management.
- Perform literature/competitive intelligence searches to recognize/resolve scientific and technical problems by applying the most current electronic document conventions and processes consistently and accurately.
- Participate on teams for process improvement initiatives and review key decisions impacting project timelines with management.
Responsible for maximizing individual, therapeutic area and team productivity; and mentor therapeutic area personnel.
