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.