Assistant Study Manager

SUMMARY

The primary responsibility is to ensure the Symphony study team is being supported in all administrative manners necessary to provide quality service and exceed the expectations of our customer. The Assistant Study Manager is responsible for maintaining all project plans for the study team, coordinating and managing the flow of study-related documents to and from clinicians and sites, reviewing and approving homecare worksheets, requesting corrections from clinician, escalating issues with documentation to the study manager in a timely manner, maintaining CRM and central study files. The Assistant Study Manager will generate and review weekly Sponsor and Vendor reports with the study manager prior to distribution to the respective stakeholders.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Administration, coordination and management of delegated study activities
• Proactive communication with clinical service providers
• Review of all homecare documentation in accordance with GCP and study specific requirements within target turnaround timeframes
• Coordination of responses from clinical service providers to queries
• Maintain Documents and Central Study Files, in accordance with GCP and study specific requirements o Assist with internal audits, and study close out activities
• Assist with Sponsor and Vendor reporting
• Keeping all internal stakeholders informed in a timely manner
• Ensure high satisfaction of all internal stakeholders
• Comply with ICH/GCP, IATA, HIPAA and other appropriate regulations

QUALIFICATIONS

• Excellent communication skills (written and verbal)
• Well-organized
• Able to multi-task
• Able to work independently or as an effective member of a team
• Attention to detail
• Proficient computer skills, including Outlook, Word, and Excel
• Adheres to timelines and due dates
• Takes initiative while following directives
• Committed to quality results

EDUCATION AND/OR EXPERIENCE

• Bachelors Degree desired, preferably in the life sciences or healthcare field
• Minimum 1-2 year relevant experience in business setting OR 1 Year Symphony experience in Study Support