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Sr. Clinical Document Specialist
| Company | Vaxcyte |
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| Location | San Carlos, CA, USA |
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| Salary | $112000 – $131000 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Senior |
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Requirements
- BA/BS degree in life sciences with a minimum of 7 years of experience in the pharmaceutical or biotechnology industry. Other combinations of education and/or experience may be considered.
- Must have industry experience managing or supporting TMF initiatives, preferably in a Sponsor or CRO environment.
- Veeva Vault eTMF experience is required.
- Strong communication skills and the ability to collaborate across teams.
- Flexible and adaptable to a fast-paced, dynamic environment.
- Excellent time management and organizational skills.
- Proficient with Microsoft Office Suite and SharePoint.
- Familiarity with clinical trial documentation and regulatory requirements across all phases of drug development.
Responsibilities
- Perform Quality Control (QC) activities within Veeva Vault eTMF in compliance with established processes.
- Serve as a member of the TMF Operations team, managing the TMF support mailbox, triaging TMF-related inquiries, and assigning tasks to appropriate team members.
- Contribute to the development of study-specific TMF Plans and TMF Indices, ensuring alignment across departments.
- Support global TMF health activities, including generating and analyzing TMF metrics, identifying trends, and escalating issues as necessary.
- Participate in system change control activities, such as User Acceptance Testing (UAT), to support system updates and improvements.
- Develop and maintain training materials, Quick Reference Guides, Standard Operating Procedures (SOPs), and Work Instructions (WIs) to ensure consistency and clarity in TMF processes.
- Assist in the delivery of high-quality eTMF system training and documentation for team members and stakeholders.
- Drive process improvement initiatives for TMF operations to enhance efficiency and compliance.
- Act as an eTMF subject matter expert (SME) during audits and provide support for audit responses.
- Collaborate on training programs to address process gaps and enhance team proficiency in eTMF operations.
- Support other TMF-related responsibilities and projects as required.
Preferred Qualifications
No preferred qualifications provided.
