Support Study Manager

Kelly; Pennsylvania; On-site; USD 55,000 - 75,000; Full time

Job summary

Kelly is seeking a Clinical Study Assistant to support operational conduct of clinical studies, assist with timelines, and coordinate with study sites and vendors. This role may support a single study or multiple studies, and may lead a focused study with limited scope.

Ideal candidates will have at least 2 years in pharmaceutical or clinical drug development, strong oral and written communication, and proficiency in Microsoft Office tools such as Outlook, Word, Excel, and PowerPoint.

Qualifications

• At least 2 years of pharmaceutical and/or clinical drug development experience in the last 5 years.
• Demonstrated oral and written communication skills.
• Proficiency in Microsoft Office applications (Outlook, Word, Excel, PowerPoint) required; OneNote experience preferred.

Responsibilities

• Assist the SM Study Lead and study team with operational conduct of clinical studies (e.g., minutes, supplies planning/tracking, lab specimen tracking, imaging data reconciliation, status reports, closeout activities).
• Support a single study or multiple studies as needed.
• May lead a study with limited scope (e.g., Survival Follow-up) and interact with internal and external stakeholders to support study objectives.
• Track study timelines and utilize project management tools to stay on schedule.

Skills

Communication skills

Oral and written communication

Project coordination

Stakeholder management

Tools

Microsoft Office

Outlook

Word

Excel

PowerPoint

OneNote

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
• May lead a study with limited scope (e.g., Survival Follow-up)
• May be responsible for tracking study timelines and will be proficient in project management tools
• May interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical study objectives

Minimum Years of Experience

• At least 2 year Pharmaceutical and/or clinical drug development experience (such as pharmaceutical/biopharma companies, hospital settings, research sites, clinical trial units, CRO, SMO) in the last 5 years required
• TA-specific experience beneficial
• Demonstrated oral and written communication skills
• Proficiency in Microsoft Office (Outlook, Word, Excel and PowerPoint) required; OneNote experience preferred.