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Dexian · 1 day ago

Central Monitor

Bethesda, MD

Full-time

Onsite

Mid, Senior Level

3+ years exp

Dexian is a leading talent and technology solutions company with a global presence. They are seeking a Central Monitor to oversee risk-based quality management and centralized monitoring processes for clinical trials, ensuring compliance with regulatory standards and providing mentorship to project teams.

ConsultingHuman ResourcesInformation TechnologyProfessional ServicesStaffing Agency

H1B Sponsor Likely

Responsibilities

Creation and ownership of risk-based quality management and centralized monitoring processes, templates, and tools corporately and for applicable clinical trials

Review protocols to ensure the set-up, review, and reporting requirements for KRIs and QTLs can be met and are standardized

Provide input and lead the study risk assessment, and propose appropriate protocol-specific risk indicators for centralized monitoring

Support setup and testing of centralized monitoring data analysis platform

Review clinical study data and make independent decisions to identify potential site performance and site organization issues, and make appropriate recommendations to CRAs for investigation and targeted activities

Train and support the project teams on interpretation of central monitoring signals and relevant decision making for study conduct

Manage operational risk log for Clinical Risk Management activities

Provide mentorship, guidance/training, and coordination for all central monitoring activities

Perform central monitoring activities including review of system dashboards and outputs, propose suggestions for signal and action management, and follow up with study team for action resolutions

Serve as Central Monitoring Subject Matter Expert (SME) during the development, implementation, and execution of central monitoring dashboards

Operate in a client-facing role to advise clients and study sponsors on industry-standard best practices for conducting centralized monitoring

Communicate effectively with cross-functional teams of CRAs, Clinical Project Managers, Clinical Trial Managers, and Data Management & Data Analytics staff

Applies a thorough understanding of regulatory (FDA requirements, GCPs/ICH guidelines), data management/ analysis, and statistical requirements in the conduct of central monitoring

Supports one or more government or commercial contracts in multiple therapeutic areas, e.g., infectious disease (vaccines and therapeutics), oncology, medical device or drug abuse

Informs division leadership on the overall status of clinical programs/projects and of potential issues/mitigation

Ensure documentation of processes and workflows are being followed and occurring within projected timelines and determine course of action to prevent and remediate delays

Maintain a high level of accuracy and attention to detail in a fast-paced environment with shifting priorities

Support and comply with the company's Quality Management System policies and procedures

Contributes to Corporate Initiatives, e.g., streamline and process improvement, SOP development, participation in proposal writing, budget development, and bid defense meetings

Supports inspection readiness of the organization and assists in department audit preparation, post inspection activities implementation and follow up

Qualification

ICH GCP knowledgeCentral monitoring experienceClinical trial regulationsCentral monitoring databaseTeam management experienceInfectious Disease backgroundOncology backgroundProblem-solving skillsPresentation skillsConflict resolution skillsAttention to detailOral communication skillsWritten communication skills

Required