Risk Manager – Clinical Research

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

📋 Description

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

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

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

• Offer recommendations for budgeting 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 into the appropriate tracking systems and ensuring ongoing oversight.

• Counsel on functional plans aimed at risk mitigation.

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

• Detect risks that may affect data quality and integrity.

• Facilitate internal and sponsor evaluations of findings.

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

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

• Report risks, deliverables that are at risk, and changes in scope to the Project Manager.

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

• Undertake additional responsibilities as assigned, contingent upon being qualified and adequately trained.

⛳️ Requirements

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

• Background in a CRO or pharmaceutical industry.

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

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

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

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

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

• High-level skills in analytical data visualization tools.

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

• Strong analytical and statistical acumen.

• Exceptional communication, negotiation, and leadership abilities.

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

• Proficient in project workflows and collaborative efforts across functions.

• Capable of training, mentoring, and organizational tasks.

• High degree of autonomy.

• Fluent in English with outstanding verbal and written communication skills.

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

• Quick learner who can grasp new concepts swiftly.

• Skills in prioritization and managing workload in response to shifting project demands.

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

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

• Effective time management while juggling multiple functions and demands.

• Experience utilizing trial management or data management systems.

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

• Must have legal authorization to work in the Philippines.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time role.

• Continuous learning and development opportunities.

• Attractive prospects for advancement.

• Recruitment and selection accommodations available for applicants with disabilities, upon request.