Senior Clinical Risk Manager

This is a fully remote position, open to applicants in Massachusetts.

📋 Description

• Oversee the creation and administration of risk assessments at the study level, which includes Risk Assessment Categorization Tools (RACTs) and integrated Quality Risk Management Plans (iQRMPs).

• Maintain risk logs to ensure precise and timely tracking of study-related risks.

• Organize regular risk review meetings to promote proactive identification and mitigation of risks.

• Offer expert insights on site risk levels, overall study health, and performance trends.

• Establish and execute study-specific monitoring strategies, incorporating risk-based monitoring techniques such as targeted Source Data Verification (SDV) or centralized monitoring.

• Document, communicate, and escalate risks to leadership when necessary.

• Monitor, trend, and report Key Risk Indicators (KRIs) to facilitate data-driven decision-making.

• Collaborate with internal teams and external vendors to handle risks, mitigation strategies, and resolution timelines for issues.

• Ensure that Contract Research Organizations (CROs) and service providers comply with Risk-Based Quality Management (RBQM) processes and expectations.

⛳️ Requirements

• Bachelor’s degree in a scientific or technical field (or equivalent experience).

• Over 8 years of experience in Clinical Operations or Development, with a minimum of 7 years dedicated to RBQM.

• Previous in-house RBQM experience is required.

• Experience at the Manager or Senior Manager level within RBQM is essential.

• Comprehensive knowledge of RBQM principles, methodologies, and implementation practices.

• Profound understanding of global clinical research regulations (e.g., ICH-GCP, 21 CFR Part 11).

• Experience assisting with regulatory inspections and audits related to RBQM.

• Demonstrated ability to lead process improvement initiatives.

• Strong collaboration skills with CROs and external partners.

• Exceptional communication, problem-solving, and risk management skills.

🏝️ Benefits

• Competitive salary and annual bonus.

• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.

• Generous parental leave and family planning benefits.

• Outstanding culture and opportunities for personal and professional growth.