Medical Monitor, Safety Administrator

🔥 1 minute ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

🧪 Clinical Research

🚫👨‍🎓 No degree required

Where this job comes from

Posted on Thermo Fisher Scientific's careers page, not through a job board

First seen by Remote Rocketship 1 minute ago

Logo of Thermo Fisher Scientific

Thermo Fisher Scientific

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

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

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