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.
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