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Clinical Data Manager II/Senior Clinical Data Manager

1 month, 1 week ago
Serbia, Slovakia, United Kingdom, Poland, Romania, Hungary
Full-time
Senior
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, ensuring continuity, responsiveness, and timely execution of tasks.
  • Oversee the project data entry process, including developing data entry guidelines, training, quality checks, and resourcing.
  • Assess timelines, manage deliverables, and help ensure clinical data management deadlines are met with quality.
  • Develop CRF specifications from the study protocol and coordinate stakeholder review and feedback.
  • Conduct database build user acceptance testing and maintain quality-controlled database build documentation.
  • Define and oversee edit check specifications and manual data review specifications.
  • Create, revise, version, and maintain data management documentation and Trial Master File records.
  • Train clinical research personnel and data management team members on CRFs, EDC, and project-related processes.
  • Review and query clinical trial data, perform line listing data review, and run patient and study-level status and metric reports.
  • Perform medical coding, coordinate SAE/AE reconciliation, and liaise with external vendors and project teams on data-related issues.

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 environment.
  • Experience with study startup, database setup, and database migrations.
  • Oncology experience preferred.
  • Proficiency in Microsoft Office: 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.
  • Professional written and oral English communication skills.
  • Ability to undertake occasional travel.

Benefits

  • Remote work flexibility, with candidates considered in the UK, Poland, Hungary, Romania, Serbia, or Slovakia.
  • Equal Opportunity Employer status.
  • Reasonable accommodation available for applicants with disabilities during the application process.
  • Privacy protections for applicant data under the company Privacy Policy and, for CA applicants, the CA Privacy Notice.

Interested in this position?

Apply directly on the company website

Apply Now

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