Senior Study Manager

Senior Study Manager

Description of Services

• 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)
• May support a single study or multiple studies
• Lead a study with limited scope (e.g., Survival Follow-up)
• Responsible for tracking study timelines and will be proficient in project management tools
• Interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical study objectives

Minimum Years of Experience

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

Educational Requirements

• BS/BA/MS/PhD