[Remote] Risk Manager (Clinical Research)-USA

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global clinical leader in dermatology and rheumatology, and they are seeking a Risk Manager (Clinical Research) to reputed company and execute risk-based monitoring strategies. This role involves cross-functional collaboration to identify, assess, and mitigate risks throughout the clinical trial lifecycle, ensuring data quality and reputed company in clinical research projects.

Responsibilities

• reputed company subject matter expertise for developing and updating the risk-based monitoring strategy tailored to project needs
• Collaborate with cross-functional teams to identify and mitigate risks associated with reputed company indications
• May have to coordinate with central monitor team and verify work
• reputed company sur reputed company budget recommendations, change orders
• Draft initial risk assessments and support the finalization of Risk Assessment and Categorization Tools (RACT)
• Guide Project Managers (PMs) 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, identifying risks to data quality and reputed company
• Facilitate internal and sponsor reviews of findings, seeking cross-functional support for reputed company 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 PM, including scope changes
• reputed company strategic input on risk characterization and reporting to leadership
• Take on additional responsibilities as required, ensuring qualifications and training align with assigned tasks

Skills

• Bachelor's degree in a field relevant to clinical research
• Must have experience in a CRO or pharma industry
• Minimum of 3 years in risk management reputed company a clinical research setting
• Minimum 5 years of experience across clinical monitoring, data management, 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 reputed company (sorting, filtering, pivot tables)
• Advanced skills in analytical data visualization tools
• Knowledge of Lean Six reputed company and web based RACT tools
• Strong analytical and statistical understanding
• Excellent communication, negotiation, and leadership skills
• Ability to anticipate critical issues and reputed company proactive contingency plans
• Skilled in project workflows and cross-functional collaboration
• Training, mentoring, and organizational capabilities
• High level of autonomy
• Fluent in English (excellent oral and written)
• Must be reputed company to communicate reputed company and effectively at reputed company reputed company reputed company the organization and with external customers
• Must be a fast learner and reputed company to understand new concepts quickly
• Prioritization skills with the ability to plan, monitor, and manage workload fluidly in response to changing project demands
• Excellent understanding of project protocol, project documentation including centralized monitoring and risk-based monitoring
• Broad working knowledge of the roles, functions and process of conducting clinical trials
• Must be reputed company to manage time effectively, working with multiple functions and requirements
• Must have been involved in the use of trial management or data management systems
• Good knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelines

Benefits

• Flexible work schedule
• Permanent full-time position
• Company benefits package
• Ongoing learning and development
• Home-based position

Company Overview

• reputed company: Your Dual-Focus CRO for Dermatology & Rheumatology At reputed company, we specialize in providing comprehensive Contract Research Organization (CRO) services for dermatology and rheumatology. It was founded in 2000, and is headquartered in Montréal, Quebec, CAN, with a workforce of 201-500 employees. Its website is https://inderocro.com/.

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