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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
Senior
Database Administrator
Database Administration
Apply Now
Precision For Medicine

Precision For Medicine

Precision for Medicine is a specialized scientific services company that helps pharmaceutical and life sciences clients innovate, develop, and commercialize next-generation medical products. With a diverse team of experts, they offer comprehensive serv...

Pharmaceuticals
1K-5K
Founded 2012
$225M raised
View All Jobs 86

Description

  • Serve as the primary data management contact for assigned clinical projects or programs and ensure continuity, responsiveness, and timely task completion.
  • Oversee the clinical trial data entry process, including data entry guidelines, training, quality checks, and resourcing.
  • Provide timeline input, track progress, and ensure clinical data management deadlines are met with quality.
  • Develop CRF specifications from the study protocol and coordinate review and feedback from stakeholders.
  • Conduct database build user acceptance testing and maintain quality-controlled database build documentation.
  • Define and oversee edit check requirements and manual data review specifications.
  • Create, revise, version, and maintain data management documentation for the Trial Master File.
  • Train clinical research personnel and data management team members on study-specific CRFs, EDC, and related project items.
  • Review, query, and perform line listing data review on clinical trial data in accordance with the Data Management Plan.
  • Perform medical coding, coordinate SAE/AE reconciliation, and run patient- and study-level status and metric reports.
  • Liaise with third-party vendors, sponsors, and project teams to support timelines and data-related deliverables.
  • Identify and troubleshoot operational issues using metrics, audit reports, and stakeholder input, and support SOP and process documentation development.

Requirements

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

Benefits

  • Remote work opportunity.
  • Role can be based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia.
  • Equal Opportunity Employer status.
  • Reasonable accommodation available for applicants with disabilities.
  • Formal recruitment and interview process with fraud protection notice.

Interested in this position?

Apply directly on the company website

Apply Now

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