8 дней назад
Medical Data Review Manager
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Medical Data Review Manager (Clinical Research): Reviewing structured clinical patient data for medical plausibility, protocol adherence, completeness, and readiness for next-level review with an accent on patient eligibility, dosing records, adverse events, laboratory results, and treatment outcomes. Focus on identifying anomalies, verifying safety-relevant information, and coordinating data issue resolution across medical review staff and clinical sites.
Location: Home-based in Buenos Aires, Argentina; global scope
Company
provides clinical research services, commercial insights, and healthcare intelligence for the life sciences and healthcare industries.
What you will do
- Review structured clinical patient data for medical plausibility, completeness, protocol adherence, and readiness for the next level of review.
- Identify anomalies in patient-reported data and coordinate further investigation with clinical sites.
- Review inclusion and exclusion criteria, investigational product dosing, adverse events, concomitant medications, and medical history.
- Assess end-of-treatment and end-of-study information to confirm the primary reason for treatment or study discontinuation.
- Review laboratory results for completeness, protocol schedule adherence, and potential unreported safety conditions.
- Coordinate with medical review staff to triage new data issues and previously identified action items; participate in kickoff, team, and client meetings.
Requirements
- Graduated Bachelor's Degree in Medicine; only physicians will be considered.
- At least 5 years of related clinical research experience at a research site, CRO, or pharmaceutical company.
- Experience as a Sub-Investigator or Principal Investigator is relevant.
- Advanced English proficiency and strong communication skills for a global-scope role.
- Understanding of clinical and medical data in clinical trials, including medical terminology, pharmacology, anatomy, and physiology.
- Strong coaching, customer focus, prioritization, collaboration, and relationship-building skills.
Culture & Benefits
- Home-based work arrangement.
- Global scope with interaction across medical review staff, clinical sites, clients, and internal stakeholders.
- Work across multiple projects and competing priorities.
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