Senior Clinical Data Risk Analyst

This is a fully remote position, open to applicants in United States.

📋 Description

• Act as the clinical risk management and central monitoring functional leader for a variety of moderate-complexity studies.

• Execute the clinical data analysis aspects of clinical studies.

• Facilitate Risk-Based Quality Management (RBQM) and plan as well as select Key Risk Indicators (KRIs) that focus on identified risks.

• Create advanced analytics and programming specifications.

• Review centrally aggregated data to pinpoint risks and issues that impact data integrity, patient safety, and regulatory compliance.

• Monitor signals, assist system users, and communicate trends to both internal and external stakeholders.

• Perform quality control and oversight activities within the Central Monitoring team.

• Lead the evaluation of clinical trial data to detect potential risks and trends that may affect study outcomes.

• Collaborate with cross-functional teams to design and implement risk mitigation strategies.

• Supervise the analysis of data discrepancies and inconsistencies, providing insights for decision-making.

• Advocate for best practices in data governance and compliance within clinical research.

• Build partnerships with stakeholders regarding risk management processes and data quality standards.

• Mentor junior staff members.

⛳️ Requirements

• Over 5 years of experience in clinical data analysis or risk management within a clinical research organization or pharmaceutical company.

• Strong analytical capabilities with expertise in statistical software and risk assessment techniques.

• High attention to detail and a proactive attitude towards identifying and resolving data risks.

• Familiarity with at least one Clinical Data Management System (e.g., Medidata RAVE, InForm, Veeva, Cluepoints, Medidata Detect, JReview, etc.).

• Capability to manage multiple studies concurrently while navigating changing priorities and competing deadlines.

• Exceptional written and verbal communication skills.

• Bachelor's degree or equivalent in life sciences or a related field is preferred.

• A combination of education, training, and relevant experience may be considered in lieu of the stated education and experience.

• Must be fluent in reading, writing, and speaking English as well as the host country language.

• Legal authorization to work in the country where the position is located.

• Applications should be submitted in English.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

• Health and wellness programs, including medical, dental, and vision coverage where applicable.

• Retirement and pension plans.

• Life insurance and disability coverage.

• Employee assistance programs and wellness resources.

• Opportunities for learning and development through structured training and career pathways.