Deciphera Pharmaceuticals logo
Deciphera Pharmaceuticals

As a member of ONO Group

Senior Clinical Risk Manager

RiskRiskFull TimeRemoteSeniorTeam 201-500Since 2016H1B SponsorCompany SiteLinkedIn

Location

Massachusetts

Posted

2 days ago

Salary

$157K - $215K / year

Seniority

Senior

Bachelor Degree8 yrs expEnglishGoogle Cloud Platform

Job Description

Senior Clinical Risk Manager

Deciphera Pharmaceuticals

• 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

Job 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.

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