Clinical Risk Manager I

Responsibilities

• Overseeing and standardizing RBQM monitoring and risk review strategies at a program/portfolio level.
• Facilitating the completion of Risk Assessment and Categorization Tools (RACT) with cross-functional leads.
• Defining custom monitoring strategies for individual studies based on scope and risk evaluations.
• Leading discussions with internal teams and sponsors to gain consensus on monitoring strategies and mitigations.
• Providing ongoing oversight for identifying and mitigating emerging risks throughout the trial lifecycle.
• Developing monitoring strategies and providing budget inputs for proposals and business development.
• What We Are Searching For:
• Bachelor's degree plus at least 6+ years of significant clinical research experience, specifically with RBQM, Central Monitoring, and Project Management.
• Subject matter expertise in ICH-GCP, ICH E6 (R3) Guidelines, RACT tools, KRI, QTLs, QbD, and budgeting.
• Prior experience with BI tools a plus, Strong Excel Expertise a plus.
• Excellent analytical, computational, judgment, and decision-making abilities.
• Proven experience collaborating with cross-functional global teams to solve complex problems.
• The ability to travel up to 20% for sponsor meetings as needed.

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Company Intel

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