Medical Monitor, Safety Administrator

• Provide contracted project coordination and safety support on global and domestic programs
• 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 via teleconference and face-to-face meetings
• Coordinate meeting logistics and assist with facilitation
• Liaise with internal and external parties to implement projects
• Prepare Confidentiality Disclosure Agreements, Letters of Intent and Member Agreements
• Review contractual documents and coordinate internal and external approvals
• Compile adjudication dossiers and create/submit follow-up to investigative sites
• Coordinate and facilitate project meetings; draft minutes and distribute meeting materials
• Post blinded and unblinded minutes/materials to client portals
• Manage project-specific training and set up, maintain and archive program files
• Ensure pharmacovigilance remains audit ready
• Identify and redact subject identifiers according to local requirements
• Retrain sites and escalate recurring issues to Data Privacy
• Perform data entry into internal/external databases, tracking systems and budget management systems
• Perform system reconciliations to identify issues that may affect project timelines
• Oversee expenses and manage translations within budget parameters
• Answer incoming hotline calls and coordinate department functions
• Support activities performed by the local office 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
• At least 2 years of previous experience providing relevant knowledge, skills, and abilities
• Equivalency through a combination of appropriate education, training and/or directly related experience may be considered sufficient
• Strong problem-solving skills
• Ability to work independently with minimal supervision and demonstrate initiative
• Ability to build strong relationships
• Ability to analyze project-specific data/systems for accuracy and efficiency
• Ability to act as a liaison and communicate respectfully and diplomatically with clients, management, project team members and internal staff
• Effective oral and 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
• Ability to maintain a positive and professional demeanor in challenging circumstances
• Flexibility to reprioritize workload according to changing project timelines
• Working knowledge of applicable FDA Regulations, ICH Good Clinical Practices, and organizational/client SOPs and WPDs for clinical and non-clinical project implementation, execution and closeout

• Potential drives to site locations and/or travel required on rare occasion
• Training provided to junior staff through role responsibilities