Clinical Study Manager I presso Celerion

As a Clinical Study Manager you are responsible for oversight and conduct of clinical studies. You will ensure compliance, quality, and profitability of clinical studies. You respond to internal and external client issues, concerns, and requests by applying study management techniques and tools. In this role you should plan to work some evening and weekends. Primary Responsibilities: You are responsible for the overall management of assigned Clinical Studies to include: ·         On-time performance with defect-free execution of each study, working with support divisions to ensure timelines are being met in clinical studies (i.e. recruiting, data management, statistics), ·         Organizing study initiation meetings to plan execution of study, ·         Facilitating study review meetings for pre-study, in-process and post study review, ·         Problem solving as needed during study conduct, ·         Meeting with clients as needed throughout study, and organizing study logistics and personnel. ·         In addition, you will be present at critical events and dosing of a study. You will build client relationships that result in additional business, you will craft and edit reports, respond to client issues, concerns and requests, adhere to milestone guidelines, and ensure profitability through budgeting and expense control on a total and individual study basis.

Primary Responsibilities - You are responsible for the overall management of assigned Clinical Studies to include:

On-time performance with defect-free execution of each study, working with support divisions to ensure timelines are being met in clinical studies (i.e. recruiting, data management, statistics),

Organizing study initiation meetings to plan execution of study,

Facilitating study review meetings for pre-study, in-Problem solving as needed during study conduct,

Meeting with clients as needed throughout study, and organizing study logistics and personnel.

In addition, you will be present at critical events and dosings of a study. You will build client relationships that result in additional business, you will craft and edit reports, respond to client issues, concerns and requests, adhere to milestone guidelines, and ensure profitability through budgeting and expense control on a total and individual study basis.

Requirements

Bachelor’s degree in a related discipline required. Clinical Trial experience may be considered in lieu of degree in some situations.

Industry experience and knowledge of medical terminology preferred.

Demonstrated organizational, time management and multi-tasking skills required

Shown 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

You will utilize customer service skills

Clinical Research experience preferred

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