Clinical Data Management Lead

3 days ago

Durham, North Carolina, United States Fortrea Full time

Job Summary:

The Clinical Data Management Lead will support the Data Manager with the review, maintenance, and update of external vendor data received from central vendors or local laboratories. This role will ensure that company SOPs, guidelines, and global standards are followed to maintain data integrity and consistency across all projects.

Key Responsibilities:

  • Develop the Vendor Data Plan (VDP), including the Data Quality Review reconciliation section, for the external vendor data transfer(s), obtain final approvals, and file the document to the Trial Master File (TMF) as applicable.
  • Responsible for communication and managing relationships with external vendors and sponsor counterparts for study expectations, including milestones, deliverable timelines, communication expectations, etc.
  • May participate in the review of external vendor Statements of Work (SOW) for study scope and ensure all protocol-specified parameters are present as applicable.
  • Ensure electronic external vendor data transfers contain all protocol-specified parameters, are in the correct format, and data populates to the specified fields and subjects correctly as designated in the Vendor Data Plan (VDP) or sponsor equivalent.
  • Develop and document external data edit checks and reports in the edit check template or sponsor equivalent, obtain approvals, and perform QC/UAT to verify the checks and reports are functioning properly.
  • Review external data discrepancies generated by edit checks and reports and perform subsequent query management to resolve data issues.
  • Maintain appropriate documentation of data issues in both study and vendor logs and follow the outcome to resolution.
  • May assist with the review of draft protocols from an external data perspective and assist with the review of eCRF design per protocol parameters.
  • Work with other study team functions to gather feedback and address any issues that could impact data review or analysis.
  • May work with clinical staff to obtain and QC local laboratory ranges and verify that the normal ranges are properly attached to the subject results in the local lab data.
  • Participate in study team and department meetings as applicable.
  • Effectively plan and support multiple increasingly complex and high-quality external data management projects simultaneously and provide updates to line management or other relevant stakeholders as requested.

Qualifications:

  • University/college degree (life sciences, health sciences, information technology, or related subjects preferred).
  • Experience and/or education plus relevant work experience, equating to a bachelor's degree, will be accepted in lieu of a bachelor's degree.
  • Fluent in English, both written and verbal.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Language Skills Required: Speaking and Writing English.

Experience:

  • 5+ years of prior experience in the pharmaceutical, biotechnology, medical device/diagnostics, or clinical trial industries, to include data management or an equivalent combination of education and experience to successfully perform the key responsibilities of the job.
  • Project Management experience is strongly preferred.
  • Basic understanding of medical terminology is a plus.
  • Strong organizational, planning, and critical-thinking skills.
  • Well-polished, inclusive, and engaging communication skills (written and verbal) to support effective interactions with sponsors and internal colleagues.

US Pay Range: $90,000-$115,000

Benefits: All job offers will be based on a candidate's skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits, including medical, dental, vision, life, STD/LTD, 401(K), ESPP, paid time off (PTO) or flexible time off (FTO), and company bonus where applicable.

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