Clinical Study Manager I

Celerion; Tempe (AZ); On-site; USD 110,000 - 140,000; Full time

Job summary

Celerion is committed to swift, exceptional clinical research through translational medicine. We seek a Clinical Study Manager in Tempe, AZ to oversee and conduct clinical studies with emphasis on compliance, quality, and profitability.

You will respond to client issues, coordinate with supporting divisions, and be required to work some evenings and weekends to ensure study milestones are met. Strong communication and customer service skills are essential.

Qualifications

• Bachelor’s degree required; clinical trial experience may be considered in lieu of degree.
• Industry experience and knowledge of medical terminology preferred.
• Demonstrated organizational, time management and multitasking skills required.
• 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.

Responsibilities

• Oversee and conduct assigned clinical studies with focus on compliance, quality and profitability.
• Ensure on-time, defect-free execution by coordinating with support divisions (recruiting, data management, statistics).
• Plan initiation meetings and organize study logistics and personnel.
• Facilitate pre-study, in-process and post-study review meetings; address issues and provide problem solving.
• Meet with clients, build relationships, craft and edit reports, respond to issues and requests.
• Ensure milestones are met and oversee budgeting and expense control for total and individual studies.

Skills

Study management

Project management

Time management

Client relations

Communication skills

Flexibility

Education

Bachelor’s degree in related discipline

Job description

Celerion is committed to swift, exceptional clinical research through translational medicine.Every day, we use our experience, agility, and innovative research strategies to help get drugs to market faster.

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

• 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

Celerion Values: Integrity Trust Teamwork Respect

Are you ready to join our team?

Celerion is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, sexual orientation, gender identity, genetic information, marital status, qualified protected veteran status, or disability.

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