Senior Clinical Risk Manager

Deciphera Pharmaceuticals

Senior Clinical Risk Manager leading the execution of Risk-Based Quality Management strategy across clinical trials. Partnering with teams to ensure high-quality study delivery and compliance.

Posted 6/26/2026full-timeRemote • Massachusetts • 🇺🇸 United StatesSenior💰 $157,000 - $215,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

Risk Assessment Categorization Tools (RACTs)integrated Quality Risk Management Plans (iQRMPs)risk-based monitoringKey Risk Indicators (KRIs)process improvementregulatory inspectionsauditsclinical research regulationsICH-GCP21 CFR Part 11

Soft Skills

leadershipcollaborationcommunicationproblem-solvingrisk management