Risk Manager

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

📋 Description

• Develop and enhance risk-based monitoring strategies specifically designed for project requirements.

• Collaborate with interdisciplinary teams to identify and address risks related to complex indications.

• Work with the central monitoring team to verify tasks as necessary.

• Offer budget suggestions and manage change orders.

• Create initial risk assessments and assist in the finalization of Risk Assessment and Categorization Tools (RACT).

• Support Project Managers in transferring recognized risks to suitable tracking systems and ensure continuous reviews.

• Provide guidance on formulating functional plans to effectively mitigate risks.

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

• Lead internal and sponsor reviews of findings, securing interdisciplinary support for intricate risks and their mitigations.

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

• Escalate risks, deliverables at risk, and scope alterations to the Project Manager.

• Offer strategic insights on risk characterization and reporting to the leadership team.

• Take on additional responsibilities as necessary, contingent on qualifications and training aligning with assigned tasks.

⛳️ Requirements

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

• Experience in a Contract Research Organization (CRO) or the pharmaceutical industry.

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

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

• In-depth knowledge of Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory standards.

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

• High level of competence in MS Excel, including sorting, filtering, and pivot tables.

• Advanced capabilities in analytical data visualization tools.

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

• Strong analytical and statistical knowledge.

• Exceptional communication, negotiation, and leadership abilities.

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

• Skilled in project workflows and cross-functional collaboration.

• Competence in training, mentoring, and organizational tasks.

• High degree of autonomy.

• Proficient 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 capable of grasping new concepts rapidly.

• Strong prioritization skills and the ability to plan, monitor, and manage workload in response to shifting project demands.

• Excellent comprehension of project protocols and project documentation, including centralized monitoring and risk-based monitoring.

• Extensive working knowledge of the roles, functions, and processes involved in conducting clinical trials.

• Ability to effectively manage time while collaborating with multiple functions and fulfilling various requirements.

• Experience utilizing trial management or data management systems.

• Solid understanding of good clinical practices and relevant Health Canada and Food and Drug Administration (FDA) regulations/guidelines.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Continuous learning and development opportunities.

• Attractive prospects for advancement.

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