Clinical Study Manager

Role Overview:

• This position supports Inspection Readiness for a high-visibility oncology protocol.
• The role involves leading CROs and ensuring all trial documents are audit-ready.

Key Responsibilities:

• Oversee document retrieval and compliance in pTMF across two CROs.
• Review and populate the Inspection Readiness checklist with document locations.
• Collaborate on protocol amendments and ICD updates as needed.

Qualifications:

• Bachelor's degree required, with strong understanding of clinical trial documents.
• Proficiency in pTMF, SOPs, and sponsor inspection processes.