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 South San Francisco Bay Area. Some hybrid remote work may be accommodated.