Clinical Risk Manager I

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

What You'll Be Doing:

• 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.