Risk Manager (Clinical Research)

Accountabilities: Provide subject matter expertise in developing, implementing, and updating risk-based monitoring strategies tailored to individual study requirements. Collaborate with cross-functional teams to identify, assess, characterize, and mitigate risks, including those associated with complex clinical indications. Coordinate with central monitoring teams when required and review their work to ensure quality and consistency. Provide budget recommendations and support the preparation of change orders when project requirements evolve. Draft initial risk assessments and contribute to the completion of Risk Assessment and Categorization Tools (RACT). Guide project managers in transferring identified risks into appropriate tracking systems and ensuring regular reviews and follow-up. Advise teams on the development of functional plans and practical mitigation strategies. Use available tools to conduct remote data reviews and centralized statistical monitoring, identifying potential threats to data quality and integrity. Facilitate internal and sponsor reviews of monitoring findings, coordinating cross-functional input for complex risks and mitigation measures. Deliver initial and ongoing training to study teams on risk assessment, centralized monitoring, and risk-based monitoring approaches. Escalate identified risks, at-risk deliverables, and potential scope changes to project managers in a timely manner. Provide strategic insights on risk characterization, monitoring outcomes, and reporting to leadership. Undertake additional responsibilities aligned with professional qualifications, experience, and required training. Requirements: Bachelor’s degree in a discipline relevant to clinical research. Mandatory professional experience within a Contract Research Organization (CRO) or pharmaceutical company. At least 3 years of experience in risk management within a clinical research environment. At least 5 years of experience across clinical monitoring, data management, and/or drug safety. Strong knowledge of Good Clinical Practice (GCP), ICH E6 (R3) guidelines, and applicable regulatory requirements, including Health Canada and FDA regulations and guidance. Demonstrated expertise in Risk-Based Monitoring (RBM) strategies, processes, and tools. Advanced proficiency in Microsoft Excel, including sorting, filtering, and pivot tables, as well as analytical data visualization tools. Knowledge of Lean Six Sigma methodologies and web-based RACT tools. Strong analytical and statistical capabilities, with the ability to interpret data and anticipate critical issues. Excellent communication, negotiation, leadership, and stakeholder management skills, including the ability to interact effectively with internal teams and external customers. Experience in training, mentoring, and supporting cross-functional teams. Strong understanding of clinical trial workflows, study protocols, project documentation, centralized monitoring, and risk-based monitoring processes. Broad knowledge of clinical trial functions and operations, with experience using trial management and/or data management systems. High level of autonomy, sound judgment, and the ability to develop proactive contingency plans. Excellent spoken and written English, with the ability to communicate complex information clearly. Strong organizational and prioritization skills, including the ability to manage multiple responsibilities, adapt to changing project demands, and coordinate effectively across functions. Ability to learn quickly, understand new concepts, and manage time effectively in a dynamic project environment. Must be legally authorized to work in India. Benefits: Permanent, full-time employment. Flexible work schedule. Ongoing learning and professional development opportunities. Stimulating and collaborative work environment. Opportunities for career growth and advancement.