Risk Manager – Clinical Research

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

📋 Description

• Create and refine risk-based monitoring strategies customized to the specific needs of projects.

• Work collaboratively with cross-functional teams to identify, evaluate, and mitigate risks related to complex indications during the clinical trial lifecycle.

• Coordinate with the central monitoring team and validate work as required.

• Offer budget recommendations and manage change orders.

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

• Advise Project Managers on transferring identified risks to suitable tracking systems and ensure continuous reviews.

• Provide guidance on creating functional plans aimed at risk mitigation.

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

• Lead internal and sponsor reviews of findings, securing cross-functional support for intricate risks and mitigations.

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

• Raise awareness of risks, deliverables at risk, 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.

⛳️ Requirements

• Bachelor's degree in a discipline pertinent to clinical research.

• Previous experience in a Contract 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 standards.

• Proficient 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.

• Solid analytical and statistical understanding.

• Outstanding 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 level of independence in work.

• Fluent in English, with superior oral and written communication skills.

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

• Quick learner able to grasp new concepts rapidly.

• Strong prioritization skills and capacity to plan, monitor, and manage workload in response to evolving project demands.

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

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

• Effective time management skills while juggling multiple functions and requirements.

• Experience with trial management or data management systems.

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

• Legally authorized to work in South Africa.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and development opportunities.

• Attractive prospects for career advancement.

• Reasonable accommodations available during the recruitment and selection process for applicants with disabilities, upon request.