„Thermo Fisher Scientific“ kuria ir tiekia technologijas, laboratorijų produktus bei farmacijos paslaugas, padedančias vykdyti mokslinius tyrimus ir teikti sveikatos priežiūrą. Įmonės veikla apima gyvybės mokslų tyrimus, analitinių problemų sprendimą, laboratorijų našumo didinimą, diagnostiką, taip pat gydymo metodų kūrimą ir gamybą. Klientams visame pasaulyje ji teikia paslaugas pasitelkdama tarptautinę komandą ir prekių ženklų portfelį, kurį sudaro „Thermo Scientific“, „Applied Biosystems“, „Invitrogen“, „Fisher Scientific“, „Unity Lab Services“, „Patheon“ ir „PPD“. Įmonės karjeros galimybės apima su šiais pasiūlymais susijusias mokslo, sveikatos priežiūros, gamybos, logistikos ir paslaugų veiklas.
Medical Monitor Safety Administrator – Mexico (Remote)
Coordinate adverse-event reviews, DSMB/EAC meetings, safety documentation, and clinical-trial operations. Support pharmaceutical and biotechnology clients across domestic and global programs.
Aprašymas
- Review protocol inquiries, serious and non-serious adverse events, diagnostic information, and Data Safety Monitoring Board data within required timelines.
- Maintain required data and produce reports for clients, project teams, and external vendors.
- Represent the DSMB/EAC Coordination Team at domestic and global committee meetings by coordinating logistics and supporting facilitation.
- Work with internal and external stakeholders to implement project activities.
- Prepare and review Confidentiality Disclosure Agreements, Letters of Intent, and Member Agreements, and coordinate their approvals.
- Assemble adjudication dossiers and prepare and submit follow-up materials to investigative sites.
- Coordinate and facilitate project meetings, prepare minutes, publish blinded and unblinded materials to client portals, and distribute meeting documents.
- Administer project training and program files, including setup, maintenance, and archiving, while maintaining pharmacovigilance audit readiness.
- Identify and redact subject identifiers, retrain sites, and escalate recurring data-privacy concerns.
- Enter data into databases, tracking tools, and budget systems, and reconcile systems to identify issues that could affect timelines.
- Monitor expenses and coordinate translations within approved budget parameters.
- Respond to incoming hotline calls and coordinate departmental activities.
- Support local-office tasks that cannot be completed elsewhere.
- Train junior staff.
Reikalavimai
- High school or secondary school diploma, or equivalent, plus a relevant academic or vocational qualification.
- Technical roles may require a certificate.
- Previous experience providing the knowledge, skills, and abilities required for the role, comparable to at least two years.
- A combination of appropriate education, training, and directly related experience may satisfy the requirements.
- Strong problem-solving ability.
- Capacity to work independently with minimal supervision.
- Ability to build effective professional relationships.
- Ability to assess project-specific data and systems for accuracy and efficiency.
- Ability to communicate respectfully and diplomatically with clients, managers, project teams, and internal staff.
- Effective verbal, written, and interpersonal communication skills.
- Advanced computer proficiency, including Microsoft Word, Excel, PowerPoint, and Access.
- Ability to prioritize and manage multiple tasks under strict deadlines.
- Strong attention to detail and accuracy.
- Flexibility to reprioritize work as project timelines change.
- Working knowledge of applicable FDA regulations, ICH Good Clinical Practice, and organizational or client SOPs and WPDs governing non-clinical and clinical project implementation, execution, and closeout.
Privalumai
- Fully remote work arrangement.
- Standard Monday-to-Friday work schedule.