TMF Administrator
4 weeks ago
Position type: Contract
Duration : 6 months
Location: Onsite – Redwood City, CA
As a TMF Administrator you will:
Principal Responsibilities Uploading documents into the TMF Performing QC of the documents in the TMF Granting/Revoking User Access Sending out weekly reports to ensure timely resolution of any outstanding Quality Issues Participating in Periodic TMF Functional QC Review cycles Participating in Completeness Checks and ensuring accuracy of the Expected Document Lists (EDLs) Participating in Oversight Reviews of CRO-owned TMFs Assisting in TMF Reconciliations as needed Supporting management with TMF activities as needed Supporting the transfer of TMFs as needed Supporting the archival of TMFs as needed Working directly with functional area content owners as needed Participating in audits and assisting with inspection readiness activities as needed KNOWLEDGE AND SKILL REQUIREMENTS Bachelor’s degree from an accredited institution or equivalent practical experience Fundamental understanding of filing systems and organization tools Knowledge and understanding of GCP/ICH and CFR Regulations Proficiency with Microsoft Office Products - Word, Excel, Powerpoint, Sharepoint Familiarity with the CDISC Trial Master File Reference Model structure (preferred) Experience with Veeva Vault Clinical (eTMF) and WingSpan
Thank you
Tevin Quick
PAY RANGE AND BENEFITS:
Pay Range*: $35/hr - $55/hr
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
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