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Clinical Data Manager II/Senior Clinical Data Manager

1 month, 2 weeks ago
Serbia, Slovakia, United Kingdom, Poland, Romania, Hungary
Lead
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 and lead for assigned clinical projects or programs.
  • Oversee the full clinical trial data management process from study start-up through post-database lock.
  • Manage project data entry activities, including data entry guidelines, training, quality, and resourcing.
  • Perform or oversee quality control of data entry as needed.
  • Develop or review CRF specifications and coordinate stakeholder feedback.
  • Conduct database build user acceptance testing and maintain controlled build documentation.
  • Oversee database quality and specify edit check and manual data review requirements.
  • Create, revise, version, and maintain data management documentation, including Trial Master File materials.
  • Train clinical research personnel and data management team members on study-specific tools and processes.
  • Review, query, and perform line listing data review on clinical trial data in accordance with the Data Management Plan.
  • Run patient-level and study-level status and metric reporting.
  • Coordinate SAE/AE reconciliation and medical coding activities.
  • Liaise with external vendors, sponsors, and project teams to support timelines and deliverables.
  • Identify and resolve operational issues using metrics, audit reports, and stakeholder input.
  • Support protocol, SAP, and CSR review when required and contribute to SOP and process documentation development.
  • Participate in bid defense preparation, client presentations, and project estimate reviews when needed.
  • Provide leadership for cross-functional and organization-wide initiatives.
  • May present software demonstrations, trainings, and project updates; may require occasional travel.

Requirements

  • Bachelor’s degree and/or a combination of related experience.
  • 5+ years of experience as a Clinical Data Manager II in a Clinical Research Organisation, Pharmaceutical, or Biotech company, or 8+ years of experience as a Senior Clinical Data Manager.
  • Experience with study setup 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, leadership, and interpersonal skills.
  • Strong verbal and written English language skills.
  • Ability to undertake occasional travel.
  • Based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia.

Benefits

  • Remote work arrangement (#LI-Remote).
  • Opportunity to join a global team.
  • Equal Opportunity Employer status.
  • Reasonable accommodation support for applicants with disabilities during the application process.

Interested in this position?

Apply directly on the company website

Apply Now

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