[Remote] Risk Manager (Clinical Research)-USA

Note: The job is a remote job and is open to candidates in USA. Indero is a global clinical leader in dermatology and rheumatology, and they are seeking a Risk Manager (Clinical Research) to develop 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 integrity in clinical research projects.ResponsibilitiesProvide subject matter expertise for developing and updating the risk-based monitoring strategy tailored to project needsCollaborate with cross-functional teams to identify and mitigate risks associated with complex indicationsMay have to coordinate with central monitor team and verify workPoint sur provide budget recommendations, change ordersDraft 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 reviewsAdvise on developing functional plans to mitigate risks effectivelyUtilize available tools to conduct remote data reviews and centralized statistical monitoring, identifying risks to data quality and integrityFacilitate internal and sponsor reviews of findings, seeking cross-functional support for complex risks and mitigationsDeliver initial and ongoing training for study teams on risk assessment, centralized monitoring, and risk-based monitoring strategiesEscalate risks or deliverables at risk to the PM, including scope changesProvide strategic input on risk characterization and reporting to leadershipTake on additional responsibilities as required, ensuring qualifications and training align with assigned tasksSkillsBachelor's degree in a field relevant to clinical researchMust have experience in a CRO or pharma industryMinimum of 3 years in risk management within a clinical research settingMinimum 5 years of experience across clinical monitoring, data management, drug safetyExpertise in Good Clinical Practice/ICH E6 (R3) Guidelines and other regulatory requirementsProficiency in Risk-Based Monitoring strategies, processes, and toolsMastery of MS Excel (sorting, filtering, pivot tables)Advanced skills in analytical data visualization toolsKnowledge of Lean Six Sigma and web based RACT toolsStrong analytical and statistical understandingExcellent communication, negotiation, and leadership skillsAbility to anticipate critical issues and develop proactive contingency plansSkilled in project workflows and cross-functional collaborationTraining, mentoring, and organizational capabilitiesHigh level of autonomyFluent in English (excellent oral and written)Must be able to communicate clearly and effectively at all levels within the organization and with external customersMust be a fast learner and able to understand new concepts quicklyPrioritization skills with the ability to plan, monitor, and manage workload fluidly in response to changing project demandsExcellent understanding of project protocol, project documentation including centralized monitoring and risk-based monitoringBroad working knowledge of the roles, functions and process of conducting clinical trialsMust be able to manage time effectively, working with multiple functions and requirementsMust have been involved in the use of trial management or data management systemsGood knowledge of good clinical practices, and applicable Health Canada and Food and Drug Administration (FDA) regulations/guidelinesBenefitsFlexible work schedulePermanent full-time positionCompany benefits packageOngoing learning and developmentHome-based positionCompany OverviewIndero: Your Dual-Focus CRO for Dermatology & Rheumatology At Indero, 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/.