Senior Manager, Global Clinical Science - Immunology
$328,440–$397,992 year
HybridWarsaw, Mazovia, Poland
Job Summary
Design and execute assigned clinical trial activities by collaborating with external partners, leading study team meetings, and developing protocol and ICF documents for governance review. Conduct literature reviews, submit clinical documents to the TMF, and create site and CRA training materials for SIVs and investigator meetings. Monitor clinical data for trends, develop data review plans, and ensure CRF design aligns with the protocol. Submit clinical contributions to clinical study reports and regulatory documents including IB, DSUR, and orphan annual reports. Requires a life sciences degree, GCP/ICH knowledge, and intermediate medical writing skills. Full-time role in Warsaw with a starting salary range of zł328,440 - zł397,992.
Required Qualifications
- Degree in Life Sciences (MD, PhD, Pharm D, MS, RN or other scientific field preferred)
- Basic knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations
- Ability to understand assigned protocol(s) and their requirements
- Basic knowledge skills to support program-specific data review and trend identification
- Intermediate medical writing skills and medical terminology
- Basic planning/project management skills (develop short range plans that are realistic and effective)
- Detail-oriented with commitment to quality
- Basic knowledge of disease area, compound, current clinical landscape
- Basic knowledge of the establishment and operation of data monitoring committees, dose review teams, and independent response adjudication committees
- Intermediate critical thinking and problem-solving skills
- Adaptable / flexible (willing and able to adjust to multiple demands and shifting priorities; ability to meet day-to-day challenges with confidence and professionalism)
- Intermediate skills in Microsoft Word/Excel/PowerPoint and data review tools (e.g., Pt Profiles, report generating tools)
Desired Qualifications
- Appropriate for new entrance to pharma (post fellowship/ new to industry)
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