Clinical Document Manager (LS-220241)
Start Date: ASAP
Location: Greater Boston
Duration: 12 months +
Pay Rate: DOE
The consultant will manage and mentor a team of 9 clinical document management specialist as they provide clinical documentation related support to programs/projects related to acquisitions of company products, eTMF on going development, inspection readiness programs, regulatory submissions support and other clinical documentation related projects.
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- Knowledge and experience of clinical documentation regulations and guidelines
- eTMF / TMF and experience managing and developing processes, protocols and SOPs for clinical documents and records.
- Practical project management experience
- Leading and/or mentoring small teams
- 10 or more years of related experience
- Must have significant eTMF / TMF experience including the use of eTMF, knowledge of ICH/GCP guidelines relating to TMF and overseeing TMF related processes.
- Working for biopharmaceutical companies or CRO’s supporting biotech
PMP certification preferred
Apply Now Clinical Document Manager (LS-220241)