Accountable for bluebird bio’s eTMF system, reporting directly to the Director, Proactive Clinical Excellence (PACE) within the Clinical Development Operations (CDO) department. Job responsibilities include the following:
Functions as bluebird’s Veeva Vault eTMF system expert, ensuring study workflows and document lifecycle follow bluebird’s SOPs.
Primary contact for end-users regarding system issues. Escalates to bluebird IT System Administrator, and/or Veeva Help Desk as appropriate.
Business owner for all Veeva Vault eTMF Change Control activities.
Create all studies in the Veeva Vault eTMF.
Review and approve eTMF user access for CDO. Liaise with IT System Administrator to ensure appropriate access is granted based on role and study.
Create, conduct, and oversee Veeva Vault eTMF training, ensuring role-based training is in place. Identify training needs for bluebird functional areas and CROs/Vendors. Partner with CDO Process and Training as needed to for all training initiatives.
Generates metrics and provides reports as directed by management. Facilitates the creation of dashboards for end users.
May conduct Quality Control (QC) review of clinical, regulatory, safety, IRB, supply chain, labs, statistics & vendor study documentation in the eTMF to assess completeness of the eTMF, adequacy of documentation, accuracy of filing based on the Master List and DIA reference model, consistency with naming conventions, and completeness of metadata. Responsible for timely resolution of QC findings and tracking progress.
May support review and development of eTMF Plans and study-specific Master Lists.
Supports the study teams and vendors to resolve discrepancies and ensure timely completion of tasks related to eTMF deliverables.
Must have MS in regulatory affairs, biomedical sciences, or related field and 5 years of biopharma/biotech industry experience supporting the operations of clinical studies, including duties related to records management and maintenance of TMF/eTMF; working with ICH-GCP, FDA, and EMA regulations; and working with DIA TMF reference model. We will also accept a BS and 7 years of stated experience.
Internal Number: bbb-eOM
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