[Remote] Risk Manager (Clinical Research)-USA
Note: The job is a remote job and is open 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
- Provide 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 provide 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
- Provide 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 able to communicate clearly and effectively at reputed company levels reputed company the organization and with external customers
- Must be a fast learner and able 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 able 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