Senior Clinical Risk Manager

🔥 5 minutes ago

🍂 Massachusetts – Remote

🍂 Massachusetts – Remote

💵 $157k - $215k / year

⏰ Full Time

🟠 Senior

🎲 Risk

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Deciphera Pharmaceuticals

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2016

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Deciphera Pharmaceuticals is a biotechnology company dedicated to defeating cancer by developing innovative kinase inhibitors to improve patient outcomes. The company focuses on designing switch-control kinase inhibitors to address mechanisms of tumor and drug resistance, aiming to enhance treatment responses for patients with cancer. Deciphera has a diverse pipeline of drug candidates, including ripretinib and vimseltinib, and is committed to making a significant impact on the lives of cancer patients. As of June 2024, Deciphera is a wholly-owned subsidiary of ONO Pharma and continues to work on improving human health through its scientific innovations and patient-centric approach.

📋 Description

• Lead the development and management of study-level risk assessments, including Risk Assessment Categorization Tools (RACTs) and integrated Quality Risk Management Plans (iQRMPs) • Maintain risk logs and ensure accurate, real-time tracking of study risks • Facilitate periodic risk review meetings and drive proactive risk identification and mitigation • Provide expert guidance on site risk levels, study health, and performance trends • Define and implement study-specific monitoring strategies, including risk-based monitoring approaches such as targeted SDV or centralized monitoring • Document, communicate, and escalate risks to leadership as appropriate • Track, trend, and report Key Risk Indicators (KRIs) to support data-driven decision-making • Partner with internal teams and external vendors to manage risks, mitigations, and issue resolution timelines • Ensure CROs and service providers adhere to RBQM processes and expectations

🎯 Requirements

• Bachelor’s degree in a scientific or technical discipline (or equivalent experience) • 8+ years of Clinical Operations or Development experience, including at least 7 years focused on RBQM • Prior in-house RBQM experience • Experience operating at the Manager or Senior Manager level within RBQM • Strong knowledge of RBQM principles, methodologies, and implementation practices • Deep understanding of global clinical research regulations (e.g., ICH-GCP, 21 CFR Part 11) • Experience supporting regulatory inspections and audits related to RBQM • Proven ability to lead process improvement initiatives • Strong collaboration skills with CROs and external partners • Excellent communication, problem-solving, and risk management capabilities.

🏖️ 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.