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Clinical Data Manager II/Senior Clinical Data Manager

1 month, 2 weeks ago
Serbia, Slovakia, United Kingdom, Poland, Romania, Hungary
Full-time
Lead
Database Administrator
Database Administration
Apply Now
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 104

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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