Clinical Development Quality Lead

4 weeks ago


Smyrna, United States Integrated Resources, Inc Full time

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


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