Risk Manager – Clinical Research

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

📋 Description

• Create and enhance risk-based monitoring strategies customized to project requirements

• Offer expert knowledge on risk-based monitoring practices

• Work collaboratively with cross-functional teams to pinpoint and alleviate risks linked to intricate indications

• Coordinate with the central monitoring team and validate work as necessary

• Recommend budget adjustments and manage change orders

• Prepare preliminary risk assessments and assist in finalizing the Risk Assessment and Categorization Tools (RACT)

• Support Project Managers in transferring recognized risks into tracking systems and ensure regular evaluations

• Provide guidance on functional strategies to address risks

• Execute remote data evaluations and centralized statistical monitoring utilizing available resources

• Recognize risks to data quality and integrity

• Facilitate internal and sponsor reviews of the findings

• Seek cross-functional assistance for complex risks and their mitigations

• Deliver initial and continuous training to 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 leadership

• Assume additional responsibilities that align with qualifications and training

⛳️ Requirements

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

• Experience in a CRO or pharmaceutical industry

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

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

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

• Expertise in Risk-Based Monitoring strategies, processes, and tools

• Proficient 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 acumen

• Exceptional communication, negotiation, and leadership abilities

• Capacity to foresee critical issues and develop proactive contingency plans

• Proficient in project workflows and cross-functional collaboration

• Skills in training, mentoring, and organizational management

• High level of independence

• Fluent in English, with outstanding oral and written communication skills

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

• Rapid learner capable of grasping new concepts swiftly

• Strong prioritization skills and the ability to plan, monitor, and manage workload in response to fluctuating project needs

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

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

• Effective time management abilities while navigating multiple functions and requirements

• Experience with trial management or data management systems

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

• Must be legally authorized to work in India

🏝️ Benefits

• Flexible work schedule

• Permanent full-time position

• Continuous learning and development opportunities

• Attractive opportunities for advancement

• Disability accommodations available throughout the recruitment and selection process, upon request