Senior Clinical Data Manager

1 hour, 5 minutes ago
Full-time
Lead
Data Science and Analytics
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

Description

  • Serve as the lead data management contact for assigned clinical projects and programs.
  • Oversee data entry processes, including guidelines, training, quality control, and resourcing.
  • Develop or oversee CRF specifications, database builds, UAT, edit checks, and manual data review specifications.
  • Create, version, maintain, and ensure the completeness of data management and Trial Master File documentation.
  • Train clinical research personnel and data management project team members on study-specific systems and processes.
  • Review and query clinical trial data, perform line-listing reviews, and generate patient- and study-level metrics.
  • Perform medical coding and coordinate SAE/AE reconciliation.
  • Manage communication and deliverables with sponsors, project teams, and third-party data and EDC vendors.
  • Identify and resolve operational issues using metrics, audit findings, and stakeholder input.
  • Contribute to SOPs, proposals, project estimates, presentations, cross-functional initiatives, and protocol, SAP, or CSR reviews as needed.

Requirements

  • Bachelor’s degree or equivalent combination of relevant experience.
  • 8+ years of experience as a Senior Clinical Data Manager or 5+ years as a Clinical Data Manager II within a CRO, pharmaceutical, or biotech company.
  • Experience with database setup and migrations.
  • Experience using various clinical database management systems.
  • Broad knowledge of drug, device, or biologic development and clinical data management practices.
  • Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.
  • Excellent organizational, communication, leadership, interpersonal, and representational skills.
  • Professional fluency in written and spoken English.
  • Oncology experience preferred.
  • Ability and legal authorization to work in the employment country without employer sponsorship; occasional travel may be required.

Interested in this position?

Apply directly on the company website

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