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11 дней назад

Clinical Data Manager (Medical Device/Pharmaceutical)

50 - 80$
Формат работы
remote (только USA)
Тип работы
parttime
Грейд
senior
Английский
b2
Страна
US
Вакансия из списка Hirify.GlobalВакансия из Hirify Global, списка международных tech-компаний
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Описание вакансии

Текст:
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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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