eTMF Specialist (Contract)

Location
Cambridge, MA, United States
Posted
Oct 24, 2018
Ref
1402967
Hotbed
Genetown
Required Education
Masters Degree/MBA
Position Type
Contract
Electronic Trial Master File (eTMF) Specialist - Contractor

Clinical-stage, fast-growing gene therapy company

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 across all clinical programs, this role is integral to ensuring that our files are complete and exceed our internal standards and regulatory requirements. This is not your typical development operations role - come make your mark with us!

About the role:
  • 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 TMF, adequacy of documentation, accuracy of filing based on the DIA reference model, consistency with naming conventions, and completeness of metadata. Responsible for timely resolution of QC findings and track progress.
  • Ensure eTMF structures comply 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.
  • Assists in creation, maintenance and archival of eTMF in accordance with Standard Operating Procedure (SOP), GCP, EMA and FDA regulations
  • Develop eTMF knowledge with progression toward subject matter expert for eTMF systems
  • Primary contact for internal and external teams regarding eTMF related processes/activities
  • Collaborate with the internal cross-functional project teams & vendors to resolve discrepancies, ensure timely completion of internal tasks related to eTMF deliverables.
  • Provide sponsor oversight of eTMF vendor(s), escalate issues for resolution
  • Provides recommended bbb eTMF metrics and drive CROs to provide equivalent metrics
  • Supports Study Team eTMF Oversight: Reviews eTMF Plan, eTMF Master Index
    • Attend study specific meetings to report on: eTMF metrics with highlighted improvements/concerns, CRO/bbb QC activities/findings/status of remediation, Summary of query/missing document trends, Define next steps
    • Provides guidance to Clinical Research Coordinators performing eTMF QC reviews
    • Performs targeted reviews of eTMF and escalates findings to study team
    • Drives ongoing process improvement, analyzes metrics/queries to develop study team training to reduce frequent errors
    • Develops processes and tools to support performance of eTMF QC activities, escalates issues as necessary to Study Leads and CDO management
    • Act as Inspection Readiness & Mock Audit core team member
      • Set-up process for granting direct inspector access to eTMF during inspections
      • Establish brief eTMF training for inspectors

About you:
  • Minimum Bachelor's degree required in a biomedical, life science, or related field of study
  • 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.
  • Thorough knowledge of the DIA TMF reference model is preferred
  • Ability to execute independently and follow-through to completion
  • Excellent organizational skills, able to multi-task in an extremely fast-paced environment
  • Excellent communication skills and ability to work across multiple functions
  • Ability to support several projects simultaneously, flexible working style and attention to detail are essential
  • Thrives in a dynamic environment
  • Excellent and transparent communication skills and ability to influence across multiple functions.
  • Positive, outgoing and collaborative attitude
  • Be ready to embrace the principles of the bluebird bio culture: b colorful, b cooperative, and b yourself