Thermo Fisher Scientific logo
Thermo Fisher Scientific

The World Leader In Serving Science

Risk Manager, Centralized Monitoring

RiskRiskFull TimeRemoteSeniorTeam 10,001+Since 1956H1B SponsorCompany SiteLinkedIn

Location

United Kingdom

Posted

1 day ago

Salary

0

Seniority

Senior

Bachelor DegreeEnglish

Job Description

Risk Manager, Centralized Monitoring

Thermo Fisher Scientific

• Lead the development, facilitation, and maintenance of study risk assessments, ensuring alignment with ICH E6(R3), RBQM principles, and Thermo Fisher quality standards. • Facilitate cross-functional risk assessment workshops to identify Critical-to-Quality (CtQ) factors, study risks, controls, and mitigation strategies throughout the clinical trial lifecycle. • Review study protocols, monitoring plans, Central Monitoring Plans (CMPs), and other key study documents to ensure risks are appropriately identified, assessed, and mitigated. • Continuously evaluate the effectiveness of risk controls and mitigation strategies through ongoing risk reviews, data analysis, and centralized monitoring outputs. • Lead periodic risk review meetings with study teams, documenting outcomes, action plans, and escalating significant risks when appropriate. • Partner with Clinical Operations, Data Management, Biostatistics, Medical Monitoring, Pharmacovigilance, and other functional areas to integrate risk management into study execution. • Represent the Risk Management function during study startup activities, including project launch meetings, Kick-Off Meetings (KOMs). • Collaborate with project leadership to develop study-specific RBQM strategies that align with protocol requirements and client expectations. • Coordinate risk management deliverables and timelines to support successful study startup and execution. • Monitor the execution of risk management activities to ensure delivery within quality, timeline, and budget expectations. • Escalate emerging risks, quality concerns, and operational issues to project leadership as appropriate. • Serve as the primary RBQM subject matter expert for assigned studies and provide consultation to study teams on risk management best practices. • Develop strong partnerships with internal functional teams and clients to promote proactive risk management and quality-focused decision making. • Represent the Risk Management function during client meetings, governance meetings, audits, inspections, and business development activities as needed. • Utilize centralized monitoring outputs, Key Risk Indicators (KRIs), Quality Tolerance Limits (QTLs), and data analytics to identify emerging risks and support risk-based decision making. • Interpret data trends and quality signals to evaluate study performance and recommend appropriate actions. • Contribute to departmental initiatives related to process improvement, quality enhancement, RBQM methodology, analytics, and technology development. • Support the development, implementation, and maintenance of RBQM standards, procedures, guidance documents, and training materials. • Provide guidance and expertise to study teams on RBQM processes, risk assessment methodology, and the application of risk management tools to support consistent execution across studies.

Job Requirements

  • Bachelor's degree in Life Sciences, Nursing, Pharmacy, Biostatistics, Data Science, or related field (advanced degree preferred).
  • Significant experience in clinical research, Clinical Operations, Central Monitoring, Risk-Based Quality Management (RBQM), or Data Analytics within a CRO or pharmaceutical environment.
  • Strong knowledge of ICH E6(R3), ICH E8(R1), FDA, EMA, and global regulatory requirements related to RBQM.
  • Experience facilitating risk assessments and developing Critical-to-Quality (CtQ) frameworks, knowledge of Key Risk Indicators (KRIs), and Quality Tolerance Limits (QTLs).
  • Strong analytical, communication, facilitation, and stakeholder management skills.
  • Experience working directly with sponsors and cross-functional global study teams.
  • Demonstrated ability to manage multiple priorities in a fast-paced global environment while driving quality and operational excellence.

Benefits

  • Work Schedule Standard (Mon-Fri)

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