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Clinical Data Manager II/Senior Clinical Data Manager

1 month ago
Serbia, Slovakia, United Kingdom, Hungary, Poland, Romania
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 109

Description

  • Serve as the primary data management contact for assigned clinical projects or programs and ensure continuity, responsiveness, and timely execution of tasks.
  • Oversee the project data entry process, including data entry guidelines, training, quality, and resourcing.
  • Conduct database build user acceptance testing and maintain quality-controlled database build documentation.
  • Develop or review CRF specifications and coordinate stakeholder review and feedback.
  • Define and oversee edit check specifications and manual data review specifications.
  • Create, revise, version, and maintain data management documentation and support Trial Master File completeness.
  • Train clinical research personnel and ensure data management team members are sufficiently trained.
  • Review and query clinical trial data according to the Data Management Plan and perform line listing data review.
  • Run patient-level and study-level status and metric reporting.
  • Perform medical coding and coordinate SAE/AE reconciliation.
  • Liaise with external vendors and communicate with sponsors and project teams on data and database issues.
  • Identify and troubleshoot operational issues using metrics, audit reports, and stakeholder input.
  • Participate in SOP development, process documentation, strategy meetings, bid defenses, and proposal or estimate reviews.
  • Provide leadership for cross-functional initiatives and may present software demonstrations or training sessions.

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 Clinical Research Organisation, pharmaceutical, or biotech company.
  • Experience with set-up and database migrations.
  • Oncology experience preferred.
  • Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
  • Excellent organizational and communication skills.
  • Professional written and spoken English.
  • Experience using various clinical database management systems.
  • Broad knowledge of drug, device, and/or biologic development and effective data management practices.
  • Strong leadership and interpersonal skills.
  • Ability to undertake occasional travel.

Benefits

  • Remote work eligibility for candidates based in the UK, Poland, Hungary, Romania, Serbia, or Slovakia.
  • Opportunity to work on global clinical trial projects.
  • Equal Opportunity Employer commitment.
  • Reasonable accommodation available for applicants with disabilities.

Interested in this position?

Apply directly on the company website

Apply Now

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