TMF Management Coordinator

2 weeks ago


Redwood City, California, United States Innova Solutions Full time
Innova Solutions is currently seeking a TMF Administrator for a contract position. This role is essential for ensuring the integrity and organization of the Trial Master File (TMF).

Position Overview:
As a TMF Administrator, your primary responsibilities will include:
  • Uploading and managing documents within the TMF system.
  • Conducting quality control checks on TMF documents.
  • Managing user access rights by granting and revoking permissions.
  • Generating and distributing weekly reports to address any outstanding quality issues.
  • Engaging in periodic quality control review cycles of the TMF.
  • Assisting in completeness checks and verifying the accuracy of Expected Document Lists (EDLs).
  • Participating in oversight reviews of TMFs managed by Contract Research Organizations (CROs).
  • Supporting TMF reconciliations as required.
  • Assisting management with various TMF-related activities.
  • Facilitating the transfer and archival processes of TMFs as necessary.
  • Collaborating with content owners from different functional areas.
  • Participating in audits and supporting inspection readiness activities.
Qualifications:
To be successful in this role, candidates should possess:
  • A bachelor's degree from an accredited institution or equivalent practical experience.
  • A solid understanding of filing systems and organizational tools.
  • Knowledge of Good Clinical Practice (GCP), International Council for Harmonisation (ICH), and Code of Federal Regulations (CFR).
  • Proficiency in Microsoft Office Suite, including Word, Excel, PowerPoint, and SharePoint.
  • Familiarity with the CDISC Trial Master File Reference Model structure is preferred.
  • Experience with Veeva Vault Clinical (eTMF) and WingSpan is advantageous.
Compensation and Benefits:
The pay range for this position is between $35/hr and $55/hr, depending on various factors such as education, work experience, and specific job duties.

Innova Solutions offers a comprehensive benefits package that may include medical and pharmacy coverage, dental and vision insurance, 401(k) plans, health savings accounts (HSA), flexible spending accounts (FSA), life insurance, pet insurance, short-term and long-term disability coverage, accident and critical illness insurance, legal and identity theft protection, sick leave, and other paid leave options as required by law, along with an Employee Assistance Program (EAP).
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