Clinical Monitoring Lead overseeing CRO activities for clinical trials at Excelya. Coordinating efforts across study phases while ensuring compliance and quality standards in a hybrid work environment.
About the role
- Leads the scientific planning and execution of clinical trials for vaccines in a global context. Collaborating across teams and ensuring integrity in trial conduct as a Senior Scientist.
Responsibilities
- This position leads the scientific planning and execution of one or more clinical trials or significant aspects thereof.
- Responsible for leading specific aspects of clinical/scientific execution of clinical protocol(s).
- Serving as the lead clinical scientist on the clinical trial team.
- Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with the Clinical Director.
- Collaborating cross-functionally in the development of Protocol and related study materials (e.g., ICF documents / amendments);
- Partners with the Study Manager on study deliverables.
- Ensuring CRF design supports data collection in alignment with the protocol in collaboration with Data Management/Programming.
- Collaborating cross-functionally to monitor clinical data to ensure quality, completeness, and integrity of trial conduct.
- Providing tactical/scientific mentorship to other clinical scientists.
Requirements
- Bachelor's degree +5 years of pharmaceutical, clinical drug development, project management, and/or medical field experience OR master's degree +3 year of pharmaceutical, clinical drug development, project management, and/or medical field experience OR PhD/PharmD degree
- Degree in life sciences, preferred.
- Accountability
- Adaptability
- Clinical Data
- Clinical Study Design
- Clinical Trial Compliance
- Clinical Trial Management
- Data Analysis
- Ethical Standards
- ICH GCP Guidelines
- Medical Writing
- Motivation Management
- Regulatory Documents
Benefits
- medical
- dental
- vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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