Risk Manager – Clinical Research

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

📋 Description

• Create and refine risk-based monitoring strategies customized to meet project requirements.

• Partner with diverse teams to recognize and address risks linked to complex indications.

• Collaborate with the central monitoring team and verify their work as necessary.

• Offer budget recommendations and manage change orders.

• Prepare initial risk assessments and assist in finalizing the Risk Assessment and Categorization Tools (RACT).

• Support Project Managers in transferring identified risks to the appropriate tracking systems and ensure continuous reviews.

• Provide guidance on functional plans to effectively mitigate risks.

• Utilize tools for remote data reviews and centralized statistical monitoring to pinpoint risks to data quality and integrity.

• Facilitate internal and sponsor reviews of findings and secure cross-functional support for complex risks and their mitigations.

• Conduct initial and ongoing training for study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies.

• Report risks or deliverables at risk, including scope changes, to the Project Manager.

• Contribute strategic insights on risk characterization and reporting to leadership.

• Undertake additional responsibilities as needed when suitably qualified and trained.

⛳️ Requirements

• Bachelor’s degree in a discipline related to clinical research.

• Experience within a CRO or pharmaceutical industry.

• At least 3 years of experience in risk management within a clinical research environment.

• Minimum of 5 years of experience in clinical monitoring, data management, and drug safety.

• Proficient in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory standards.

• Expertise in Risk-Based Monitoring strategies, processes, and tools.

• Advanced skills in MS Excel (sorting, filtering, pivot tables).

• Strong proficiency in analytical data visualization tools.

• Familiarity with Lean Six Sigma and web-based RACT tools.

• Excellent analytical and statistical acumen.

• Exceptional communication, negotiation, and leadership abilities.

• Capacity to foresee critical issues and devise proactive contingency plans.

• Skilled in project workflows and cross-functional collaboration.

• Capable of training, mentoring, and organizational tasks.

• High degree of autonomy.

• Fluent in English (excellent verbal and written communication skills).

• Ability to communicate effectively and clearly at all organizational levels and with external clients.

• Quick learner capable of grasping new concepts swiftly.

• Strong prioritization skills with the capacity to plan, monitor, and manage workload adaptively in response to shifting project demands.

• Comprehensive understanding of project protocols and documentation, including centralized and risk-based monitoring.

• Broad knowledge of the roles, functions, and processes involved in conducting clinical trials.

• Ability to manage time efficiently while juggling multiple functions and requirements.

• Experience with trial management or data management systems.

• Solid understanding of good clinical practices and relevant Health Canada and FDA regulations/guidelines.

• Must have the legal right to work in Bulgaria.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and development opportunities.

• Attractive career advancement prospects.

• Engaging work environment.