Senior Clinical Data Risk Analyst

Accountabilities

• • Lead clinical data risk management and central monitoring activities across multiple moderate-complexity clinical studies.
  • Facilitate risk-based quality management (RBQM) activities, including risk identification, assessment, planning, and mitigation.
  • Evaluate clinical trial data to identify risks, trends, discrepancies, and emerging issues that could affect study outcomes, data integrity, patient safety, or regulatory compliance.
  • Define and select Key Risk Indicators (KRIs) aligned with identified study risks and develop appropriate analytical approaches.
  • Design advanced analytics requirements and programming specifications to support centralized monitoring and risk detection.
  • Review centrally aggregated clinical data and interpret signals to identify potential risks and determine appropriate follow-up actions.
  • Track signals, trends, and risk findings while communicating relevant insights to internal and external stakeholders.
  • Conduct quality-control and oversight activities within centralized monitoring processes.
  • Analyze data discrepancies and inconsistencies and provide recommendations that support informed clinical and operational decision-making.
  • Collaborate with cross-functional teams to develop and implement effective risk mitigation strategies and maintain high standards of data quality.
  • Provide guidance on data governance, compliance, and clinical research best practices.
  • Build strong stakeholder partnerships to ensure alignment around risk management processes, analytical approaches, and data-quality expectations.
  • Provide mentoring, guidance, and knowledge sharing to junior team members.
  • Support system users and contribute to effective communication of clinical data trends and risk-related findings.

  Requirements

  • 5+ years of experience in clinical data analysis, clinical risk management, or a related discipline within a clinical research organization, pharmaceutical company, or comparable environment.
  • Bachelor’s degree or local equivalent, preferably in life sciences or a related field; an equivalent combination of education, training, and relevant experience may be considered.
  • Strong analytical capabilities, including experience applying statistical software, data-analysis techniques, and clinical risk-assessment methodologies.
  • Practical knowledge of risk-based quality management and centralized monitoring principles within clinical research.
  • Experience working with at least one Clinical Data Management System or clinical analytics platform, such as Medidata RAVE, InForm, Veeva, Cluepoints, Medidata Detect, JReview, or similar tools.
  • Strong ability to identify patterns, trends, discrepancies, and potential data risks with a high level of attention to detail.
  • Experience developing or applying Key Risk Indicators, risk signals, or other data-driven monitoring approaches is highly valuable.
  • Ability to manage several clinical studies simultaneously while adapting to changing priorities and competing deadlines.
  • Strong problem-solving skills and a proactive approach to identifying risks and developing practical mitigation strategies.
  • Excellent written and verbal communication skills, with the ability to present complex analytical findings clearly to technical and non-technical stakeholders.
  • Strong collaboration skills and the ability to establish effective working relationships across multidisciplinary teams.
  • Demonstrated ability to mentor and support less-experienced colleagues.
  • Fluent English communication skills are required, along with fluency in the applicable host-country language where required.
  • Applicants must have the legal right to work in the United States.

  Benefits

  • Remote work: Fully remote position based in the United States.
  • Compensation: Competitive base salary with potential performance-related incentives.
  • Healthcare: Medical, dental, and vision coverage, where applicable.
  • Retirement: Retirement and pension plan options.
  • Financial protection: Life insurance/assurance and disability coverage.
  • Wellbeing: Employee assistance programs and resources supporting physical and mental wellbeing.
  • Professional development: Structured training, learning opportunities, and career-development pathways.
  • Inclusive workplace: Commitment to an accessible and inclusive working environment.
  • Career growth: Opportunities to develop expertise in clinical risk management, centralized monitoring, data analytics, and clinical research.