Medical Monitor – Safety Administrator

• Coordinate timely review of protocol inquiries, serious and non-serious adverse events, diagnostics and Data Safety Monitoring Board data
• Track required data and generate reports for clients, project teams and external vendors
• Represent the DSMB/EAC Coordination Team at global and domestic committee meetings, coordinating logistics and assisting with facilitation
• Interface with internal and external parties to implement projects
• Prepare and review Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements, coordinating approvals
• Compile adjudication dossiers and create/submit follow-up to investigative sites
• Coordinate and facilitate project meetings, draft minutes, post blinded and unblinded materials to client portals, and distribute materials
• Manage project-specific training and program file setup, maintenance and archival while keeping pharmacovigilance audit ready
• Identify and redact subject identifiers, retrain sites and escalate recurring issues to Data Privacy
• Perform data entry into databases, tracking systems and budget management systems; reconcile systems to identify timeline-impacting issues
• Oversee expenses and manage translations within budget parameters
• Answer incoming hotline calls and coordinate department functions
• Support local-office activities that cannot be performed elsewhere
• Provide training to junior staff

• High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
• Technical positions may require a certificate
• Previous experience providing the knowledge, skills, and abilities to perform the job, comparable to at least 2 years
• An equivalency consisting of a combination of appropriate education, training and/or directly related experience may be sufficient
• Strong problem-solving skills
• Ability to work independently with minimal supervision
• Ability to build strong relationships
• Ability to analyze project-specific data/systems for accuracy and efficiency
• Effective liaison and respectful, diplomatic communication with clients, management, project team members and internal staff
• Effective oral, written communication and interpersonal skills
• Excellent computer skills, including MS Office (Word, Excel, PowerPoint, Access)
• Ability to prioritize and perform multiple tasks simultaneously under strict deadlines
• Strong attention to detail and accuracy
• Flexibility to reprioritize workload to meet changing project timelines
• Working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and organizational/client SOPs and WPDs for non-clinical and clinical project implementation, execution and closeout

• Fully remote work arrangement
• Standard Monday–Friday work schedule