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Ateka Bashir

@atekabashir

Clinical operations leader with 7+ years streamlining clinical trials and TMF governance.

United States
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What I'm looking for

I’m looking for a clinical operations role where I can lead study start-up and TMF governance, partner with sponsors/CROs/IRBs, and protect activation timelines through tight risk tracking, audit-ready documentation, and strong cross-functional execution.

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

AL

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 logoUA

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 logoBM

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.

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