Clinical Risk & RBM Specialist I

Premier Research Group

United States

Remote

USD 90,000 - 150,000

Full time

14 days+

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Job summary

Premier Research Group is seeking a Clinical Risk Manager I to join our Clinical Management team in the United States. You will help biotech, medtech, and pharmaceutical partners translate science into medicines, devices and diagnostics, while contributing to risk-based monitoring and integrated risk management.

The role emphasizes RBQM leadership, risk assessment, QTL development and cross-functional collaboration, with up to 20% travel for sponsor meetings.

Qualifications

Significant clinical research experience with RBQM, Central Monitoring and Project Management.
Expertise with ICH-GCP and ICH E6 guidelines and RACT tools preferred.
Strong analytics, data interpretation and decision-making abilities.

Responsibilities

Support Bidder, Proposals and Business Development by outlining monitoring strategy based on risk assessment.
Complete the study RACT for complex/global trials with cross-functional mitigations.
Evaluate and establish QTL parameters with required functions.
Ensure the proposed RBM strategy is fit for purpose and risk proportionate.
Coordinate data reviews via analytics and provide tools for Central Monitor as applicable.
Author the Integrated Quality Risk Management Plan for assigned studies.
Serve as SME on Risk Management and RBM for assigned studies.
Support cross-functional protocol execution risk reviews throughout the project life cycle.
Assist Kick Off meetings for new awards and opportunities.