about 1 month ago
Hamlyn Williams is partnered with an exciting CRISPR, Precision Oncology biotech organization that is looking to urgently hire an eTMF Specialist for their Clinical Operations team in MA. This role reports to the Associate Director, Clinical Operations, and the successful candidate will be able to start immediately.
- Lead eTMF kick-off meeting for studies, ensuring roles are assigned as per eTMF SOP.
- Driving the creation of eTMF Plans, and Study-specific Master Lists.
- Assist in the maintenance of the eTMF in accordance with Standard Operating Procedures, ICH-GCP, EMA, and FDA regulations.
- Function as eTMF representative on Clinical Study Teams for multiple projects
- Provide Study teams with relevant reports and outputs to support TMF Quality.
- Actively works to collect feedback to promote end-user adoption, acceptance, and an active user community for the TMF.
- B.S. degree required and 2 years experience working in clinical operations, with the focus on maintenance of TMF/eTMF.
- Veeva Vault system experience preferred.
- Strong knowledge of ICH-GCP, FDA, and EMA regulations.
- Experience with metrics, reporting, and business intelligence tools.