bluebird bio’s growing Clinical Development Operations team is setting the standard for trial design, conduct, and analysis in gene therapy. Join our collaborative, creative and passionate team as we help bring the promise of gene therapy to patients with severe genetic disease and cancer.
By reviewing and overseeing our eTMFs, this role is integral to ensuring that our files are complete and exceed our internal standards and regulatory requirements.
This is not your typical contract development operations role – come make your mark with us!
What you will do all day:
- Conduct Quality Control (QC) review of clinical study documentation in the eTMF to assess completeness of the TMF, adequacy of documentation, accuracy of filing based on TMF table of contents, consistency with naming conventions, and completeness of metadata.
- Generate prompt QC status reports and communicate the results to the study team leads.
- Ensure timely resolution of QC findings and track progress.
- Ensure eTMF structures are in compliance with regulatory guidance, internal bluebird bio standards, and will ensure rapid retrieval of documents during regulatory inspections.
- Provide input on the revision of TMF-related SOPs, WIs, and internal TMF-related tools.
This is your dream job if you have:
- Minimum of 3 years industry experience in supporting the operations of clinical studies, including duties related to records management and maintenance of TMF/eTMF
- Good working knowledge of FDA, MHRA, and ICH GCP regulations, guidelines, and standards governing regulated clinical research, essential documentation, and good documentation practices.
- Ability to execute independently and follow-through to completion
- Detail-oriented with good problem solving ability
- Excellent organizational skills, sufficient to multi-task in an extremely fast-paced environment
- Excellent communication skills and ability to work across multiple functions
Even better if you have:
- Thorough knowledge of the DIA TMF reference model
- eTMF experience, specifically with TrialInteractive
bluebird bio will only accept job applications from candidates who are properly documented with authorization to work in the United States.
Note to Employment Agencies: Please do not forward any agency resumes. bluebird bio is not responsible for any fees related to resumes that are unsolicited.