Risk Manager, Clinical Research

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

📋 Description

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

• Work collaboratively with cross-functional teams to pinpoint and alleviate risks related to complex indications.

• Liaise with the central monitoring team and validate work as necessary.

• Offer budget suggestions and manage change orders.

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

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

• Provide counsel on functional plans for effective risk mitigation.

• Execute remote data reviews and centralized statistical monitoring utilizing available tools.

• Detect risks to data quality and integrity.

• Facilitate internal and sponsor reviews of findings.

• Seek cross-functional assistance for intricate risks and their mitigations.

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

• Escalate risks, deliverables at risk, and scope alterations to the Project Manager.

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

• Take on additional responsibilities that correspond with qualifications, experience, and training.

⛳️ Requirements

• Bachelor’s degree in a field pertinent to clinical research.

• Experience in a CRO or pharmaceutical industry.

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

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

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

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

• Advanced proficiency in MS Excel, including sorting, filtering, and pivot tables.

• Strong skills in analytical data visualization tools.

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

• Robust analytical and statistical knowledge.

• Exceptional communication, negotiation, and leadership abilities.

• Capacity to anticipate critical issues and formulate proactive contingency plans.

• Proficient in project workflows and cross-functional collaboration.

• Capable of training, mentoring, and organizing effectively.

• High degree of autonomy.

• Fluent in English, with excellent verbal and written communication skills.

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

• Quick learner, able to grasp new concepts swiftly.

• Strong prioritization skills and the ability to plan, monitor, and manage workload in response to evolving project needs.

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

• Extensive working knowledge of clinical trial roles, functions, and processes.

• Ability to manage time efficiently across multiple functions and requirements.

• Experience with trial management or data management systems.

• Good knowledge of good clinical practices and relevant Health Canada and FDA regulations/guidelines.

• Must be legally authorized to work in Poland.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and development opportunities.

• Attractive prospects for advancement.

• Equal opportunity and accommodations throughout the recruitment and selection process, upon request.