Pharvaris - a clinical-stage company focused on bringing an oral bradykinin B2 receptor antagonist to patients - is seeking a highly motivated Clinical Lead Data Manager to join and provide complete and consistent clinical data for statistical analysis following international standards defined by health authorities
This position is within a highly collaborative and international department that strives to achieve high quality and excellent results. This role may be based in the Boston area (MA USA), Zug (Switzerland) or in Leiden, the heart of biotech in The Netherlands and reports to the Chief Medical Officer, who is based in the USA. We offer talented staff a great working environment, dedicated and driven co-workers, short lines of communications and an attractive compensation package
Key Characteristics
Activities concerning the preparation of the processing of clinical data:
- Act as a Lead Data Manager on specific clinical trials
- Give input to the design of CRFs and databases according to the study protocols
- Review and approve (coordinate the sign off) the designed databases and CRFs according to SOPs and protocols
- Develop data entry and data review guidelines
- Test developed guidelines with the created databases
Activities concerning the validation of clinical data.
- Review and validate clinical data to ensure consistency, integrity and accuracy according to GCP/ICH and based on project-specific guidelines
- Query (by producing Data Correction Forms) investigators and clinical monitors regarding inconsistencies and errors in clinical data
- Process the information given by investigators/ clinical monitors and validate again until the quality of the data is optimal
- Coordinate database QC audit
- Coordinate database lock (QC, following checklist, coordinate with other staff)
- Discuss with central laboratories and/ or Contract Research Organizations (CROs) on the delivering of data
Education and experience
- Degree (BSc) in a scientific, preferably biomedical discipline
- Minimum 5-7 years of experience in data management in CRO or pharmaceutical/biotech R&D
- Experience in international drug development in a multicultural environment
- Active knowledge of ClinTrial or a similar data management/database application
- Analytical approach
- Accuracy and an eye for detail working with clinical data
- Result-oriented attitude and can-do mentality
- Clear and intelligent communicator, both verbally in project teams and written in reporting. Fluent in scientific and business English.