Risk Manager (Clinical Research)-Romania
Finance
Excel
WFA Digital Insight
The demand for skilled risk managers in the clinical research sector has risen significantly, with a 25% increase in job openings over the past year. As the pharmaceutical industry continues to evolve, professionals with expertise in risk-based monitoring strategies and data analysis are in high demand. Indero, a leading company in the field, is seeking an experienced Risk Manager to join their team. With the shift towards remote work, this role offers the opportunity to work with a global team and develop a career in a rapidly growing industry. Before applying, candidates should be aware of the importance of staying up-to-date with regulatory requirements and industry trends.
Job Description
About the Role
As a Risk Manager at Indero, you will play a crucial role in developing and executing risk-based monitoring strategies for clinical trials. Your expertise will ensure data quality and integrity, supporting the seamless implementation of Risk-Based Study Management principles. You will collaborate with cross-functional teams to identify, assess, and mitigate risks throughout the clinical trial lifecycle. The role involves working closely with project managers, data managers, and other stakeholders to develop and implement risk management plans. Your ability to analyze complex data sets and identify potential risks will be essential in this position. You will also be responsible for providing training and guidance to study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies. Indero is a dynamic company that values innovation and collaboration. As a Risk Manager, you will be part of a global team that is passionate about delivering high-quality clinical trials.What You Will Do
- Develop and update risk-based monitoring strategies tailored to project needs
- Collaborate with cross-functional teams to identify and mitigate risks associated with complex indications
- Coordinate with central monitor teams and verify work
- Provide budget recommendations and change orders
- Draft initial risk assessments and support the finalization of Risk Assessment and Categorization Tools (RACT)
- Guide Project Managers in transferring identified risks to the appropriate tracking systems and ensure ongoing reviews
- Advise on developing functional plans to mitigate risks effectively
- Utilize available tools to conduct remote data reviews and centralized statistical monitoring
- Identify risks to data quality and integrity
- Facilitate internal and sponsor reviews of findings, seeking cross-functional support for complex risks and mitigations
- Deliver initial and ongoing training for study teams on risk assessment, centralized monitoring, and risk-based monitoring strategies
- Escalate risks or deliverables at risk to the Project Manager, including scope changes
- Provide strategic input on risk characterization and reporting to leadership
What We Are Looking For
- Bachelor’s degree in a field relevant to clinical research
- Minimum 3 years of experience in risk management within a clinical research setting
- Minimum 5 years of experience across clinical monitoring, data management, and drug safety
- Expertise in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory requirements
- Proficiency in Risk-Based Monitoring strategies, processes, and tools
- Mastery of MS Excel, including sorting, filtering, and pivot tables
- Advanced skills in analytical data visualization tools
- Knowledge of Lean Six Sigma and web-based RACT tools
- Strong analytical and statistical understanding
- Excellent communication, negotiation, and leadership skills
- Ability to anticipate critical issues and develop proactive contingency plans
- Skilled in project workflows and cross-functional collaboration
- Training, mentoring, and organizational capabilities
- High level of autonomy
- Fluent in English, with excellent oral and written communication skills
Nice to Have
- Experience with trial management or data management systems
- Knowledge of good clinical practices and applicable Health Canada and FDA regulations/guidelines
- Certification in clinical research or a related field
- Experience with centralized monitoring and risk-based monitoring
Benefits and Perks
- Competitive salary and benefits package
- Opportunity to work with a global team and develop a career in a rapidly growing industry
- Flexible working hours and remote work options
- Professional development and training opportunities
- Access to cutting-edge technology and tools
- Collaborative and dynamic work environment
- Recognition and reward for outstanding performance
- Comprehensive health insurance and wellness programs
- Generous paid time off and holiday allowance
- Retirement savings plan and employee stock options
- Remote stipend and home office setup support
How to Stand Out
- Tip: Make sure to highlight your experience with risk-based monitoring strategies and data analysis in your application.
- Tip: Be prepared to provide examples of how you have identified and mitigated risks in previous roles.
- Tip: Show your knowledge of regulatory requirements and industry trends, and explain how you stay up-to-date with the latest developments.
- Tip: Emphasize your ability to work collaboratively with cross-functional teams and communicate complex information effectively.
- Tip: Be ready to discuss your experience with tools such as MS Excel, analytical data visualization tools, and trial management systems.
- Tip: Research the company culture and values, and be prepared to explain why you are a good fit for the role and the company.
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