Clinical Data Risk Manager

This is a fully remote position, open to applicants in Mexico, +5 more countries.

📋 Description

• Implement and manage RBQM procedures at the study level.

• Review study protocols and aid in the creation of Study Risk Assessments to define critical data, essential processes, key risk indicators, and quality tolerance limits.

• Create study-specific content and lead RBQM training sessions and kick-off meetings.

• Draft and execute study-specific RBQM plans.

• Facilitate risk assessment and risk review meetings with cross-functional study teams.

• Collaborate with RBQM system configuration teams to ensure the functionality of risk indicators, quality tolerance limits, analytics, and visualizations as needed.

• Conduct periodic central monitoring of aggregate data at the study, region, country, site, and patient levels.

• Detect emerging risks and issues, facilitating root cause identification and mitigation strategies.

• Ensure that corrective and preventive actions are documented, assigned, and executed.

• Monitor the effectiveness of risk mitigation actions and suggest necessary adjustments.

• Generate signal and trending reports for study teams.

• Collaborate with Adaptive Monitoring Excellence on signals that require modifications to targeted source data verification and source data review plans.

• Maintain precise documentation of RBQM activities.

• Assist in internal and external audits, inspections, and regulatory interactions.

• Uphold quality, consistency, and compliance with RBQM procedures across studies.

• Identify and disseminate best practices, case studies, failures, and opportunities for process improvement.

• Serve as a change agent, champion, subject matter expert, and point of contact for RBQM methodology.

• Potentially oversee junior staff within RBQM Operations.

⛳️ Requirements

• Bachelor’s Degree in a health-related, life science area, or an international equivalent is preferred, or an equivalent combination of education, training, and work experience.

• Minimum of 6 years of experience in the pharmaceutical or CRO industry.

• At least 2 years of experience in Risk Based Quality Management.

• Minimum of 2 years of managerial and supervisory experience.

• Strong understanding of the drug development process and execution of clinical trials.

• Familiarity with industry regulatory standards including 21 CFR Part 11, ICH E6, and ICH E8 (GCP).

• Experience in risk management, sponsor audits, health authority inspections, root cause analyses, mitigation strategies, and Corrective Actions Preventive Actions.

• Knowledge of RBQM IT systems or other data analytic systems.

• Proven ability to analyze data, recognize patterns, and make recommendations for improvement.

• Demonstrated capability to effectively lead cross-functional team meetings.

• Experience in forming cross-functional collaborations.

• Strong interpersonal skills.

• Ability to influence without authority.

• Pragmatic mindset and willingness to drive and support change.

• Comfortable operating in ambiguous situations.

• Excellent teamwork, organizational, interpersonal, and problem-solving abilities.

• Assertive and collaborative communication style.

• Aptitude for data analytics with a strong analytical mindset.

• Attention to detail and critical thinking skills.

• Capability to effectively communicate cross-functionally with individuals at various levels.

• Legal right to work in the country where the role is based.

🏝️ Benefits

• Competitive base salary along with performance-related incentives.

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

• Retirement and pension plans.

• Life assurance and disability coverage.

• Employee assistance programs and wellbeing resources.

• Learning and development opportunities through structured training and career pathways.

• Reasonable accommodations during the recruitment process.

• Equal opportunity and inclusive workplace.