Kshama Broussard
Clinical Trial Project Management | Drug Development & Clinical Operations
- Role
- Study Management Associate at AbbVie
- Location
- Houston, TX, US
- LinkedIn followers
- 500 followers
About Kshama Broussard
Clinical Trial Manager with 10+ years of progressive experience in global clinical…
Experience
Study Management Associate
Jan 2022 — Present
AbbVie titling; role is equivalent to Clinical Trial Manager Study Management- Responsible for the day-to-day execution and on-time delivery of Phase 2/3 global clinical trials (startup through closeout). Lead/manage activities for country assignments- Manage CROs and external vendors (central labs, IRT, ancillary supply), associated budget reviews,contracting, invoicing, oversight plans, and issue management/resolution - Author study protocols, study related documents and internal plans (study materials, ICFs, trainings, sponsor communications)- Evaluate recruitment vendors and implement internal workflows for enrollment acceleration - Lead and drive CDSO related study efforts, provide input/review of EDC specs/CRF design, use Excel and data review techniques to perform clinical data review activities - Manage data snapshots and interim/final data locks, review/troubleshoot edit checks, conduct review of entered data for logic/expectations with scientific/medical leads, and manage/address deficiencies- Skilled presenter and meeting facilitator. Comfortable developing agendas/presentations, identifying stakeholders, and leading internal/external (site/investigator facing) meetings for groups of 10-200. Change/Process Improvement Champion- Participant in process improvement and subject matter expert initiatives, mentor/onboard new hires- CTMS Issue Management SME (emphasis in system design/workflow/functionality)- Supported Project Gemini as an Issue Management SME- Supported Project GLOW to streamline enterprise critical projects
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