Clinical Study Manager I

Celerion•Tempe, AZ

About The Position

Celerion is committed to swift, exceptional clinical research through translational medicine, using its experience, agility, and innovative research strategies to help get drugs to market faster. The Clinical Study Manager is responsible for oversight and conduct of 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. Some evening and weekend work is expected. The manager oversees assigned clinical studies from planning through completion, coordinating with support divisions and clients to meet timelines and milestones. The role includes organizing study meetings, managing study logistics and personnel, attending critical events and dosing, preparing reports, and controlling study budgets and expenses to support profitability.

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

Manage assigned clinical studies and ensure on-time, defect-free execution.
Work with support divisions, including recruiting, data management, and statistics, to ensure study timelines are met.
Organize study initiation meetings to plan study execution.
Facilitate pre-study, in-process, and post-study review meetings.
Solve problems as needed during study conduct.
Meet with clients throughout studies and respond to their issues, concerns, and requests.
Organize study logistics and personnel.
Attend critical events and study dosing.
Build client relationships that result in additional business.
Craft and edit reports.
Adhere to milestone guidelines.
Ensure profitability through budgeting and expense control on total and individual study bases.
Ensure compliance and quality in clinical studies.