Clinical Studies Specialist - job 1 of 2

Job Summary

A company is looking for a Clinical Studies Specialist II.

Key Responsibilities:

• Maintain inspection readiness by reviewing eTMF reports and ensuring data integrity
• Lead reconciliation, review, archival, and QC of master files
• Support audits/inspections and review regulatory documents for IP release

Qualifications:

• Bachelor's/Master's degree with 2+ years in a clinical environment is required
• Experience with TMF/eTMF is required
• Experience with clinical documentation management is required
• Experience with Veeva Vault or Vault Clinical is preferred
• Knowledge of TMF audit readiness and experience in oncology therapeutic area is preferred