Colleen G.
Study Manager
- Role
- Study Manager at Parexel
- Location
- Tampa, FL, US
- LinkedIn followers
- 500 followers
About Colleen G.
Many years of clinical trial operations experience in multiple therapeutic areas (oncology, immuno-oncology, transplantation, infectious disease, neurology, hematology, rheumatology, and cardiology) at six major pharma companies in both phases and IV. Innovative professional with proven leadership skills, placing high expectations on quality of work and an exceptional ability to identify gaps/inefficiencies in current processes to streamline and improve. Capable of managing many projects simultaneously while mentoring/training colleagues and providing oversight of external vendors.
Experience
Study Manager
Jul 2021 — Present
Co-manages operations of two sister study protocols; collaborating with clinical, data management, drug supply, vendors, and field personnelVendor oversight; manages/reviews documentation and updates of Lab manuals, site communications, change orders, etc; specimen management and sample reconciliationTrial Master File oversight and reconciliation until completion; drives filing timelines; performs inspection readiness checks Updates to study documentation: ADI log, Site Monitoring plan, CTT details, List of SOPs, Training logs, CSR appendices, etc.
Education
St. Petersburg College
Associate of Science - AS, Health Sciences
2014 — 2018
St. Petersburg College
Bachelor of Applied Science - BASc, Health Services Administration
2018 — 2020
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