Job Description Summary #LI-Hybrid Location: Cambridge, MA or East Hanover, NJ The Trial Master File (TMF...) Compliance Lead will be responsible for the Translational Clinical Oncology (TCO) strategy on TMF and Document Management System...
Pharmaceuticals, Inc. is seeking a Senior Trial Master File (TMF) Specialist to join as an integral member of the Clinical operations... compliance risks. Lead efforts to identify, communicate, and resolve document inconsistencies, discrepancies, and gaps. Work...
and inspection readiness of all Data Management Trial Master File (TMF) documents. Ensures achievement of major data management... of managing or mentoring other [junior] CDM Staff. They will lead cross-functional team members to perform proper Data Reviews...
in alignment with the therapeutic study Conducts routine completeness checks of the Trial Master File (TMF) to ensure compliance... are appropriately escalated to the Clinical Operations Program Lead (COPL) Ensures trial adherence to ICH/GCP/Federal and local...