Position Summary / Objective
- Responsible for design and execution of assigned clinical trial activities and work closely with clinical team members to execute activities associated with trial conduct.
- May serve as Clinical Trial Lead for one or more trials.
- May lead or support trial level activities for one or more trials with necessary supervision.
- May co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members.
Position Responsibilities
- Collaborate and liaise with external partners (e.g., KOLs).
- Seek out and enact best practices.
- Provide regular and timely updates to manager/management as requested.
- Develop Protocol and ICF documents/amendments and present to governance committee and development team meetings.
- Conduct literature review.
- Submit clinical documents to TMF.
- Develop site and CRA training materials and present at SIVs and Investigator meetings.
- Review clinical narratives.
- Monitor clinical data for specific trends.
- Develop Data Review Plan with Data Management.
- Ensure CRF design supports data collection aligned with protocol (with Data Management/Programming).
- Submit clinical contributions to CSRs and clinical portions of regulatory documents and contribute to regulatory submissions.
Degree Requirements
- Degree in Life Sciences (MD, PhD, PharmD, MS, RN or other scientific field preferred).
Experience Requirements
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations.
- Ability to understand assigned protocol requirements.
- Basic skills for program-specific data review and trend identification.
- Intermediate medical writing skills and medical terminology.
- Basic planning/project management skills.
Key Competencies
- Detail-oriented; commitment to quality.
- Basic knowledge of disease area/compound/clinical landscape.
- Basic knowledge of data monitoring/dose review/independent response adjudication committees.
- Intermediate critical thinking/problem-solving.
- Adaptable/flexible.
- Intermediate MS Word/Excel/PowerPoint and data review tools.
Travel Required
- Domestic and international travel may be required.