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/presentations related to clinical trials using available software and templates and; review/contribute to clinical protocols, by utilizing expertise, to assist in interpretation of data.
- 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 studies.
- Apply experience to analyze clinical study data, including statistical data using available software to assist with ongoing blinded/un-blinded PK, safety and efficacy reviews and ensure the scientific integrity of all processes.
- Responsible for receiving and completing tasks and assignments from function, Therapeutic Area MD or Scientific Staff within timeline with minimal supervision and; maximizing individual, function/therapeutic area and team productivity.
- Lead the study development by applying most current electronic document conventions/processes most consistently/accurately to ensure scientific integrity of all processes.
- Participate on teams for process improvement initiatives and review key decisions impacting project timelines with 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.
- Provide/present key clinical study information to function/therapeutic area and management.
• May lead teams within function/therapeutic area and supervise exempt and/or non-exempt direct reports and mentor function/therapeutic area personnel.
This is a hybrid opportunity that requires to be onsite 3x/week in Lake County, IL
