Senior Study Manager

Job Description

Senior Study Manager

Description of Services

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• Assists the SM Study Lead and study team with the operational conduct of clinical studies (e.g., CTT minutes, clinical supplies planning/tracking, lab specimen tracking, imaging data reconciliation, status update reports, study closeout activities)
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• May support a single study or multiple studies
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• Lead a study with limited scope (e.g., Survival Follow-up)
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• Responsible for tracking study timelines and will be proficient in project management tools
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• Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical study objectives
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Minimum Years of Experience

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• At least 7 years Pharmaceutical and/or clinical drug development experience (such as pharmaceutical/biopharma companies, CRO) in the last 5 years required
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• 2 years experience leading global studies
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• TA-specific experience beneficial (Oncology preferred)
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• Demonstrated oral and written communication skills
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• Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required; OneNote experience preferred.
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Educational Requirements

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• BS/BA/MS/PhD
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