Trial Master File Specialist - Redbock - an NES Fircroft company

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.