Ateka Bashir
@atekabashir
Clinical operations leader with 7+ years streamlining clinical trials and TMF governance.
What I'm looking for
I’m a clinical operations professional with 7+ years supporting Phase I–IV clinical trials across psychiatry, ophthalmology, and dermatology, with experience on both the site and sponsor sides. I bring end-to-end capability in study start-up, site activation, regulatory submissions, essential document management, and trial execution.
On the sponsor side, I led a full Veeva Vault eTMF implementation at Galderma Laboratories, improving documentation efficiency by 75%. I also delivered GCP and eTMF governance training to 500+ global clinical operations professionals at Alcon-Novartis, and I’ve served as an operational lead across 10 concurrent Phase I–IV studies, managing PI changes and site relocations while protecting activation timelines.
Most recently, as a Lead Clinical Research Coordinator with AIM Trials, I drive regulatory transitions and site activation across 10 concurrent studies, coordinating directly with sponsors, CROs, and IRBs to land 50–80+ submissions without missing deadlines. I keep regulatory and essential documents audit-ready in Veeva Vault and CRIO eRegulatory, build readiness tracking in Airtable, and support monitoring visits (SIV/IMV/COV) while ensuring ICH-GCP and FDA compliance.
Experience
Work history, roles, and key accomplishments
Epidemiology Specialist
Tarrant County Public Health Department
Oct 2020 - Apr 2021 (6 months)
Used SAS to run COVID-19 trend analysis and provided the county team data needed to respond in real time. Maintained HIPAA-compliant case tracking systems and supported CDC guidance for vaccination and response efforts.
Global Site Onboarding Coordinator
Alcon-Novartis
Jan 2016 - Jan 2017 (1 year)
Built onboarding and training infrastructure for global clinical site management teams to standardize operational practices. Delivered monthly training to 500+ attendees on eTMF governance, CTMS workflows, and GCP compliance, using real audit examples to improve learning.
Education
Degrees, certifications, and relevant coursework
University of Massachusetts Amherst
Master of Public Health, Biostatistics
2016 - 2019
Master of Public Health with a focus in Biostatistics at the University of Massachusetts Amherst from 2016 to 2019.
Boston University School of Medicine
Bachelor of Science, Biomedical Lab and Clinical Sciences
2006 - 2011
Bachelor of Science in Biomedical Lab and Clinical Sciences at Boston University School of Medicine from 2006 to 2011.
Tech stack
Software and tools used professionally
Availability
Location
Authorized to work in
Job categories
Skills
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