Clinical Data Manager (Medical Device/Pharmaceutical)
Контакты
50 - 80$
Формат работы
remote (только USA)
Тип работы
parttime
Грейд
senior
Английский
b2
Страна
US
project managementrisk managementmicrosoft excelregulatory compliancepharmaceuticalsclinical trialsmedical devicesclinical data managementeclinical systems
Вакансия из Hirify Global, списка международных tech-компаний Для мэтча и отклика нужен Plus
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В Company hidden четко описана роль в клиническом управлении данными в регулируемой medtech-сфере, но срок от шести месяцев и занятость 20 часов в неделю ограничивают стабильность дохода и долгосрочные перспективы.
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Временная занятостьПонятные задачиСфера медтехаТолько США
Оценка от Hirify AI
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Текст:
Hirify AI/Оригинал
TL;DR
Clinical Data Manager (Medical Device/Pharmaceutical) (Clinical Trials/Data Management): Leading clinical data management activities across study startup, conduct, closeout, and reporting with an accent on data quality, regulatory compliance, and cross-functional collaboration. Focus on overseeing CROs and vendors, managing electronic clinical data capture systems, training clinical research associates, and maintaining GCP-compliant documentation.
Location: Remote from a US home office; applicants must be eligible to live and work in the US. The role is temporary for an initial 6-month assignment, may be extended, and requires 20 hours per week. Occasional business travel of 0–5% may be required, with willingness and ability to work on site.
Salary: $50.00–$80.00 per hour.
Company
hirify.global develops medical device products and operates clinical research and regulated quality systems.
What you will do
Lead and perform data management activities across clinical study startup, conduct, closeout, and reporting.
Serve as the data management subject matter expert on multidisciplinary project teams, contributing to timelines, deliverables, and resource planning.
Oversee data management CROs and other vendors for compliance with protocols, GCPs, regulatory guidelines, SOPs, and applicable standards.
Maintain data management documentation and support audits, inspections, reporting, and study progress tracking.
Collaborate with Data Management, Biostatistics, Clinical Affairs, and Medical Affairs teams to ensure data integrity and quality.
Create training materials and train CRAs, investigators, and other teams on consistent clinical data entry and data management practices.
Requirements
Bachelor's degree with 5+ years of experience in a medical device, pharmaceutical company, or similar environment such as a CRO, or an equivalent combination of education and experience.
Experience working on regulatory trials in the medical device and/or pharmaceutical industry.
Experience with electronic clinical trial data capture systems, such as iMedidata Rave, InForm, eClinicalOS, or RedCap.
Thorough knowledge of clinical data management practices and all aspects of data management.
Knowledge of regulatory guidelines related to data quality and data management, as well as quality systems, compliance, privacy, and security principles.
Technical, organizational, analytical, and strong communication skills.
Ability to manage change and multiple priorities, work independently, achieve results, and maintain a positive service-oriented attitude.
Knowledge of continuous improvement, project management, change management, and risk management.
Proficiency with Microsoft Word, Excel, and PowerPoint.
Ability to communicate accurately with employees at all levels and perform extended computer-based office work, including preparing emails, documents, and spreadsheets.
Ability to move within the office, access supplies and file cabinets, move between buildings and floors, and lift or move up to 25 pounds; potential exposure to blood-borne pathogens.
Nice to have
Master’s degree with 3+ years of clinical research experience, preferably in a pharmaceutical company.
CCDM certification.
Culture & Benefits
Temporary part-time assignment with an initial duration of six months and possible extension.
Remote work from a US home office with occasional travel to conferences or affiliated facilities.
Work within hirify.global’s quality management system and domestic and global regulatory standards.
General office working environment with opportunities to contribute to department improvements, SOPs, and processes.
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