Clinical Study Manager I

Celerion•Tempe, AZ

About The Position

The Clinical Study Manager is responsible for overseeing and conducting clinical studies, ensuring compliance, quality, and profitability. The role responds to internal and external client issues, concerns, and requests using study management techniques and tools. The manager works with support divisions to meet study timelines, organizes study meetings and logistics, and is present at critical study events and dosing. The position involves building client relationships, preparing and editing reports, adhering to milestone guidelines, and managing budgets and expenses to support profitability. Some evening and weekend work may be required.

Requirements

Bachelor’s degree in a related discipline; clinical trial experience may be considered in lieu of a degree in some situations.
Demonstrated organizational, time-management, and multitasking skills.
Ability to handle multiple priorities.
Excellent oral and written communication skills.
Ability to work without close supervision.
Ability to work flexible hours required for study conduct.
Customer service skills.

Nice To Haves

Industry experience and knowledge of medical terminology.
Clinical research experience.

Responsibilities

Oversee and manage assigned clinical studies.
Ensure on-time, defect-free study execution and coordinate with support divisions, including recruiting, data management, and statistics, to meet timelines.
Organize study initiation meetings to plan study execution.
Facilitate pre-study, in-process, and post-study review meetings.
Solve problems arising during study conduct.
Meet with clients as needed and organize study logistics and personnel.
Attend critical study events and dosing.
Build client relationships that may result in additional business.
Craft and edit reports.
Respond to client issues, concerns, and requests.
Adhere to study milestone guidelines.
Ensure profitability through budgeting and expense control for individual studies and overall study work.