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Clinical Data Manager II/Senior Clinical Data Manager

2 hours, 4 minutes ago
Serbia, Slovakia, United Kingdom, Hungary, Poland, Romania
Full-time
Lead
Database Administrator
Database Administration
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Precision Medicine Group

Precision Medicine Group

Precision Medicine Group specializes in precision medicine, utilizing targeted expertise and data insights to accelerate drug development and enhance the commercialization of next-generation medical products for the pharmaceutical and life sciences ind...

Pharmaceuticals
251-1K
Founded 2012
View All Jobs 130

Description

  • Serve as the primary data management contact for assigned clinical projects or programs and ensure continuity and timely task execution.
  • Oversee the clinical trial data entry process, including data entry guidelines, training, quality, and resourcing.
  • Review and query clinical trial data in accordance with the Data Management Plan.
  • Develop or support CRF specifications and coordinate stakeholder review and feedback.
  • Conduct database build user acceptance testing and maintain quality-controlled database documentation.
  • Oversee the quality of the clinical database and define edit check and manual data review requirements as needed.
  • Create, revise, version, and maintain data management documentation and Trial Master File completeness.
  • Train clinical research personnel and ensure data management team members are sufficiently trained.
  • Perform medical coding, SAE/AE reconciliation, status reporting, and metric reporting.
  • Liaise with external vendors, sponsors, and project teams to support timelines and data deliverables.

Requirements

  • Bachelor’s degree and/or a combination of related experience.
  • 8+ years of experience as a Senior Clinical Data Manager or 5+ years as a Clinical Data Manager II in a CRO, pharmaceutical, or biotech company.
  • Experience with database setup and database migrations.
  • Experience using various clinical database management systems.
  • Oncology experience preferred.
  • Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
  • Strong organizational, communication, leadership, and interpersonal skills.
  • Professional written and verbal English communication skills.
  • Broad knowledge of drug, device, and/or biologic development and effective data management practices.
  • Ability to undertake occasional travel.

Benefits

  • Remote work is available for candidates based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia.
  • The role is posted as #LI-Remote.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support is available for candidates who need assistance with the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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