Clinical Scientist/Senior Clinical Scientist
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Job Description
Join Catalyst Clinical Research as a Clinical Scientist responsible for data assessment and clinical trials overview while working in a remote role across Europe.
Responsibilities:
- Review, understand, and assess clinical data before it is reviewed by Medical/Client.
- Communicate and present the relevant trends and findings of the clinical review to the Study Team and the Client.
- Ensure that the clinical database and regulatory projects maintain the highest level of integrity.
- Collaborate with Client, subcontractors, and Study Team members to meet project timelines and Client expectations for clinical data review.
- Review CRFs, data quality review plans, and other clinical study reports as needed.
- Propose methods to improve collaboration, efficiency, and excellence in data-related review deliverables to the Chief Scientific/Medical Officer, Clinical Operations and Biometry.
- Partner with Study Team in the development of data review plans for individual clinical studies.
- Provide continuous review and interpret relevant clinical data, applying clinical expertise to derive meaningful insights.
- Analyze and track potential safety events within a given trial and across trials for assigned programs.
- Contribute to discussions with Study Team and/or Client regarding modifications in the study and/or strategy based on clinical review.
Requirements:
- Advanced clinical/science degree (e.g., PharmD, PhD, MSN, MPH, etc.) preferred.
- 8 or more years of industry/related experience OR Bachelor’s degree in a life-science or nursing with 12 years or more of industry/research related experience including reviewing and interpreting data.
- Extensive and direct knowledge of the clinical development process as well as principles of study design.
- Comprehensive understanding of product and safety profiles.
- Experience in the principles and techniques of data analysis, interpretation, and clinical relevance.
- Experience with electronic data capture systems and data visualization tools.
- Well-versed in GCP, ICH, and relevant regulatory requirements.
- Proficient with Microsoft Office Suite, inclusive of Excel, PowerPoint, Word.
- Strong organizational, problem-solving, and analytical skills.
- Proven ability to handle multiple projects and meet deadlines.
- Ability to deal effectively with a diversity of individuals at all organizational levels.
Benefits:
- Flexible working arrangements
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