Clinical Document Management Specialist II
New
O
OraOphthalmic clinical research
Remote - USFull-TimeMiddle
Salary not disclosed
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Job Details
- Experience
- 3 years experience with clinical documentation and 3 years experience with record management systems (eTMF)
Requirements
- Bachelor’s degree in a relevant field.
- Minimum 3 years experience with clinical documentation.
- Minimum 3 years experience with record management systems (eTMF) in clinical research.
- Familiarity with ICH GCP, DIA TMF Reference Model, and regulatory guidelines/directives.
- Familiarity with eTMF and CTMS software.
- Prior experience working in a CRO environment.
- Strong attention to detail and document organization skills.
- Ability to work independently and manage deadlines.
- Strong communication skills for internal and external collaboration.
Responsibilities
- Implement and administer document management systems and procedures.
- Perform QC review of clinical and regulatory documents for eTMF entry.
- Monitor compliance and drive documentation issue resolution.
- Prepare documentation for regulatory agency inspections and internal audits.
- Act as a Veeva Vault Super-user providing training and support to team members.
- Assist in the development of work processes, SOPs, and content classification taxonomies.
- Coordinate the close-out and archiving of clinical documentation.
- Generate metrics reports for periodic review of study files.
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