Central Risk Manager based in Philippines

📋 Description

• • Provide expert advice and subject matter guidance on the development and refinement of risk-based monitoring strategies for clinical trials, ensuring alignment with protocol, ICH/GCP, Good Pharmacoepidemiology Practices (GPP), and local regulatory requirements.
• • Collaborate with cross-functional leads to analyze complex therapeutic indications and identify study-specific risks, ensuring consistent risk mitigation approaches across programs, therapeutic areas, and sponsors.
• • Draft initial risk assessments and support project teams in finalizing Risk Assessment and Control Plans (RACT), ensuring comprehensive cross-functional input and documentation.
• • Ensure all identified risks are accurately transferred to the appropriate tracking systems and facilitate ongoing cross-functional reviews throughout the study lifecycle.
• • Evaluate and leverage available tools for remote data review and centralized statistical monitoring to detect risks to data quality and integrity.
• • Facilitate structured reviews of monitoring findings with internal teams and sponsors, escalating complex risks and coordinating input from functional leads for mitigation planning.
• • Assist in defining Quality Tolerance Limits (QTLs) in collaboration with internal stakeholders and sponsors, where required.
• • Develop and deliver initial and ongoing training to study teams on risk assessment methodologies, centralized monitoring techniques, and the broader risk-based monitoring strategy.
• • Coach and mentor peers on functional delivery, evaluation of project risks, and implementation of risk mitigation actions.
• • Ensure inspection readiness by aligning risk assessment and centralized monitoring activities with compliance standards and regulatory expectations.
• • Maintain a thorough understanding of assigned study scope, budget, and protocol content to inform risk-based decisions and resource allocation.
• • Proactively escalate any risks to timeline, quality, or budget related to risk assessment and centralized monitoring deliverables, as well as any activities outside contracted scope, to the Project Manager.
• • Contribute to business development efforts by providing input on monitoring strategy design, budget estimation, and proposal development for new opportunities.
• • Work in alignment with functional areas including Medical Monitoring, Safety, and Quality Assurance to ensure integrated risk management across all study components.
• • Support the implementation of monitoring plans that reflect evolving regulatory expectations and industry best practices in risk-based monitoring.
• • Maintain awareness of global regulatory landscapes and ensure monitoring strategies comply with country-specific regulations applicable to trial sites.
• • Act as a key point of contact for risk-related inquiries from internal teams and sponsors, providing timely, accurate, and actionable guidance.
• • Contribute to continuous improvement of risk-based monitoring processes through feedback, lessons learned, and process optimization initiatives.