Medical Monitor – Safety Administrator

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Facilitate timely evaluations of protocol inquiries, serious and non-serious adverse events, diagnostics, and Data Safety Monitoring Board data.

• Monitor necessary data and produce reports for clients, project teams, and external vendors.

• Represent the DSMB/EAC Coordination Team in both global and domestic committee meetings, managing logistics and providing facilitation support.

• Collaborate with both internal and external stakeholders to implement projects.

• Draft and review Confidentiality Disclosure Agreements, Letters of Intent, and Member Agreements, ensuring proper approvals are secured.

• Assemble adjudication dossiers and create/submit follow-ups to investigative sites.

• Organize and facilitate project meetings, take minutes, upload blinded and unblinded materials to client portals, and distribute necessary documentation.

• Oversee project-specific training and maintain program file setups, ensuring they remain audit-ready for pharmacovigilance.

• Identify and redact subject identifiers, retrain sites, and escalate recurring issues to Data Privacy.

• Enter data into databases, tracking systems, and budget management systems; reconcile these systems to pinpoint timeline-impacting issues.

• Manage expenses and handle translations within budget constraints.

• Respond to incoming hotline inquiries and coordinate departmental functions.

• Assist with local-office activities that cannot be executed elsewhere.

• Provide training to junior team members.

⛳️ Requirements

• High/Secondary school diploma or equivalent, along with relevant formal academic/vocational qualifications.

• Technical roles may necessitate a specific certificate.

• Prior experience that provides the necessary knowledge, skills, and abilities for the role, equivalent to a minimum of 2 years.

• An equivalency of appropriate education, training, and/or directly related experience may be acceptable.

• Strong problem-solving abilities.

• Capability to work independently with minimal oversight.

• Ability to foster strong relationships.

• Proficiency in analyzing project-specific data/systems for both accuracy and efficiency.

• Effective liaison skills and respectful, diplomatic communication with clients, management, project team members, and internal staff.

• Strong oral and written communication skills, along with interpersonal abilities.

• Excellent computer proficiency, particularly with MS Office (Word, Excel, PowerPoint, Access).

• Ability to prioritize and manage multiple tasks simultaneously under tight deadlines.

• Meticulous attention to detail and accuracy.

• Flexibility to adjust workload priorities to align with changing project timelines.

• Familiarity with applicable FDA Regulations, ICH Good Clinical Practices, as well as organizational/client SOPs and WPDs for non-clinical and clinical project implementation, execution, and closure.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.