Senior Clinical Data Risk Analyst

Meet Life Sciences; Bilbao; Híbrido; EUR 70.000 - 100.000; Jornada completa

Descripción de la vacante

Join a leading global CRO as a Senior Clinical Data Risk Analyst, where you will contribute to innovative therapies and data quality through expert risk-based monitoring. In this role, you'll lead clinical evaluations and work cross-functionally to drive risk strategies that support high-quality clinical trials, all while enjoying a flexible remote or hybrid work setting.

Formación

• 5+ years of professional experience specifically within RBQM / clinical risk management.
• Strong knowledge of KRIs, QTLs, and central monitoring methodologies.
• Proven experience leading global projects within RBQM.

Responsabilidades

• Lead clinical data evaluations to identify risks and trends.
• Develop study-specific central monitoring and data surveillance strategies.
• Collaborate with cross-functional teams to implement risk mitigation strategies.

Conocimientos

Risk-Based Quality Management

Data Analytics

Statistical Monitoring

Communication

Stakeholder Management

Educación

Advanced degree in Biostatistics, Data Science, Life Sciences, or related field

Herramientas

CluePoints

Elluminate

Descripción del empleo

We are partnering with a leading global CRO to support the search for a Senior Clinical Data Risk Analyst . This is a unique opportunity to join a world-renowned organisation at the forefront of clinical research, contributing directly to the development of innovative therapies and ensuring data quality through expert risk-based monitoring.

As a Senior Clinical Data Risk Analyst, you’ll take a central role in assessing and mitigating clinical trial data risks across multiple global studies. You’ll work cross-functionally with clinical teams to develop central monitoring plans, ensure regulatory compliance, and guide data-driven decision-making.

Key Responsibilities

Lead clinical data evaluations to identify risks and trends affecting study outcomes

Drive study-level risk assessments and central monitoring discussions with global study teams

Review and interpret KRIs, QTLs, and statistical monitoring outputs across regions

Develop study-specific central monitoring and data surveillance strategies

Serve as the primary contact and subject matter expert for statistical monitoring tools

Collaborate with cross-functional teams to implement risk mitigation strategies

Oversee the analysis of data discrepancies and provide insights to inform key decisions

Promote compliance and data governance best practices across clinical operations

Maintain central monitoring documentation and contribute to audit readiness

Ideal Candidate Profile

5+ years of professional experience specifically within RBQM / clinical risk management

7+ years of total experience in the pharmaceutical or clinical research industry

Proven experience leading global projects within RBQM or central monitoring

Strong, hands-on experience with either CluePoints (RBM) or Elluminate (EDC) – both not required

Data-focused profile – candidates must have direct experience with analytics and system use (not oversight only)

Advanced degree in Biostatistics, Data Science, Life Sciences, or related field

Strong knowledge of KRIs, QTLs, and central monitoring methodologies

Excellent communication and stakeholder management skills

This role offers the opportunity to work in a global, dynamic environment with the flexibility of remote or hybrid working within Poland. You’ll be instrumental in shaping risk strategies that directly support the delivery of safe, high-quality clinical trials.

Interested in learning more?

Apply today or reach out for a confidential discussion.