Job Title: Clinical Development Quality Lead
Job Location: Smyrna, GA
Job Duration: 12 Months
Job Description:
Clinical Development Quality Lead
Notes from HM:
Looking for an experienced Clinical Quality Assurance professional to support inspection readiness activities for key clinical program. This role will involve working cross-functionally with internal departments and external organizations, such as CROs, to resolve quality issues to ensure inspection preparedness. Specific responsibilities will include:
Co-lead inspection preparation meetings with team with a focus on inspection preparation at the study level for a key program.
Reviewing study related documentation to ensure it is inspection ready.
Conduct Quality Control checks of the eTMF.
Support data integrity assessments.
Support the inspection readiness of investigator sites.
Conduct inspection risk assessments for CROs and vendors.
Provide guidance on compliance and regulations and ensure study teams are following targeted SOPs during study.
Help SMEs in the development of storyboards and functional area presentations.
The ideal candidate will possess:
Knowledge and interpretation of GCP regulations and standards, with understanding of phase appropriate application of GCP expectations.
Direct experience with FDA and/or EMA or other health authority inspections of sponsor, investigator site(s), and/or CRO(s).
Self-motivated with the ability to take initiative, ownership and manage responsibilities while shifting priorities quickly under tight timelines.
Strong analytical skills, problem solving techniques, and understanding of ensuring level of effort to address observations/quality issues is commensurate with risk.
Education Level
Bachelors