Senior Study Manager

Kelly Science, Engineering, Technology & Telecom; United States; On-site; USD 90,000 - 120,000; Full time

Job summary

A leading clinical research organization in the United States is seeking an experienced professional to assist in the operational conduct of clinical studies. The ideal candidate will have over 7 years of pharmaceutical or clinical drug development experience and at least 2 years of experience leading global studies. Strong project management skills and proficiency in Microsoft Office are essential, with an emphasis on communication. Oncology experience will be beneficial for success in this role.

Qualifications

• At least 7 years of experience in pharmaceutical or clinical drug development.
• 2 years experience leading global studies.
• Demonstrated oral and written communication skills.
• Proficiency in Microsoft Office (Outlook, Word, Excel, and PowerPoint).

Responsibilities

• Assist the SM Study Lead and study team with operational conduct of clinical studies.
• Support a single study or multiple studies.
• Lead a study with limited scope.
• Track study timelines and proficiently use project management tools.
• Interact with internal and external stakeholders.

Skills

Project management

Communication skills

Proficiency in Microsoft Office

Tools

Microsoft Office

Job description

• 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.