Redbock - an NES Fircroft company | Trial Master File Specialist

6 days ago


san francisco, United States Redbock - an NES Fircroft company Full time

TRIAL MASTER FILE SPECIALIST


SUMMARY:

Consultant needed to provide TMF support, quality control and oversight.


DUTIES & RESPONSIBILITIES:

* QC and full lifecycle management of clinical trial documents

* Support and manage TMF, and related communications and reporting

* Support TMF workflow optimization, problem identification, trend analysis, etc.

* Support inspections and audits

* Other duties, as required


QUALIFICATIONS & REQUIREMENTS:

* 5 years of focused trial master file experience in the pharmaceutical / biopharmaceutical industy(ies)

* 3 years of Veeva Vault eTMF skills and experience, and thorough expertise in GCP, ICH, ALCOA+, FDA and International Regulatory standards and requirements

* Experience managing TMF matters and related documents during regulatory agency inspections

* Bachelor's Degree


LOCATION:

Work will be performed onsite in the greater San Francisco Bay Area. Some hybrid remote work may be accommodated.



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