Risk Manager – Clinical Research

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

📋 Description

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

• Work together with cross-functional teams to pinpoint and alleviate risks linked to complex indications.

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

• Provide recommendations for budgets and manage change orders.

• Prepare preliminary risk assessments and assist in the completion of Risk Assessment and Categorization Tools (RACT).

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

• Offer advice on functional plans to effectively mitigate risks.

• Perform remote data reviews and centralized statistical monitoring to detect risks to data quality and integrity.

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

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

• Raise awareness of risks, at-risk deliverables, and scope changes to the Project Manager.

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

• Take on additional responsibilities that align with qualifications and training.

• Collaborate with clinical research teams at Indero, a clinical research organization specializing in dermatology and rheumatology.

⛳️ Requirements

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

• Experience in a clinical research organization (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.

• In-depth knowledge of Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory requirements.

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

• Advanced expertise 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.

• Solid analytical and statistical understanding.

• Exceptional communication, negotiation, and leadership abilities.

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

• Proficient in project workflows and collaboration across functions.

• Capable of training, mentoring, and organizational tasks.

• High level of independence.

• Fluent in English (both oral and written communication).

• Ability to communicate clearly and effectively at all levels within the organization and with external clients.

• Quick learner with the ability to grasp new concepts rapidly.

• Strong prioritization skills with the capacity to plan, monitor, and manage workload dynamically in response to changing project needs.

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

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

• Ability to effectively manage time while collaborating with multiple functions and requirements.

• Experience with trial management or data management systems.

• Good understanding of good clinical practices and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

• Legally authorized to work in the Czech Republic.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and development opportunities.

• Attractive career advancement prospects.

• Commitment to equitable treatment and equal opportunity.

• Accommodations in recruitment and selection for applicants with disabilities, upon request.