Risk Manager – Clinical Research

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

📋 Description

• Develop and enhance risk-based monitoring strategies customized to meet project requirements.

• Offer expert knowledge for the creation of risk-based monitoring strategies.

• Work in collaboration with cross-functional teams to identify and address risks related to complex indications.

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

• Provide recommendations for budget adjustments and change orders.

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

• Support Project Managers in transferring identified risks to the appropriate tracking systems and ensure regular reviews.

• Advise on the formulation of functional plans to mitigate risks.

• Utilize tools for conducting remote data reviews and centralized statistical monitoring, identifying risks to data quality and integrity.

• Facilitate internal and sponsor reviews of findings.

• Seek support across functions for complex risks and their mitigations.

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

• Escalate risks or deliverables at risk, including changes in scope, to the Project Manager.

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

• Take on additional responsibilities in line with qualifications and training.

• Collaborate with colleagues throughout a global clinical research organization that supports dermatology and rheumatology trials.

⛳️ 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 in clinical monitoring, data management, and drug safety.

• Proficiency in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory standards.

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

• Advanced proficiency in MS Excel, including sorting, filtering, and pivot tables.

• High-level skills 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.

• Capability to foresee critical issues and devise proactive contingency plans.

• Proficient in project workflows and cross-functional teamwork.

• Skills in training, mentoring, and organizational tasks.

• High degree of autonomy.

• Fluent in English, with strong oral and written communication skills.

• Ability to convey information clearly and effectively at all organizational levels and to external clients.

• Quick learner with the capacity to grasp new concepts rapidly.

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

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

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

• Ability to manage time efficiently while juggling multiple functions and requirements.

• Experience with trial management or data management systems.

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

• Must possess legal eligibility to work in Romania.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Opportunities for ongoing learning and development.

• Attractive prospects for advancement.

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