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Ocugen is seeking a TMF Lead to ensure TMF quality, completeness, and inspection readiness across trials within the Veeva Vault eTMF system. You will lead TMF activities from startup through closeout, collaborating with Clinical Operations, Regulatory Affairs, Data Management, and CROs/vendors.
Responsibilities include developing TMF management plans, monitoring KPIs, performing TMF health checks, and driving CAPAs to support audits and regulatory inspections.
Ocugen is seeking a TMF Lead to ensure TMF quality, completeness, and inspection readiness across trials within the Veeva Vault eTMF system. You will lead TMF activities from startup through closeout, collaborating with Clinical Operations, Regulatory Affairs, Data Management, and CROs/vendors.
Responsibilities include developing TMF management plans, monitoring KPIs, performing TMF health checks, and driving CAPAs to support audits and regulatory inspections.