Offer summary

Qualifications:

Bachelor’s Degree in biological, behavioral, or computer science., At least 2 years of clinical data management experience., Experience with MediData Rave or OmniComm TrialMaster., Knowledge of ICH/GCP guidelines and regulatory requirements..

Key responsibilities:

Conduct pre-entry review of clinical data.

Review and issue data queries based on automated checks and sponsor requirements.

Ensure accuracy and integrity of clinical databases.

Assist with data management documentation and training.

Job description

What You'll Do:

Conduct pre-entry review of clinical data
Review and issue queries for case report form (CRF) data based on automated edit checks, manual review, and sponsor requirements
Ensure accuracy of clinical databases as compared to the CRF and the result of any data queries
Code concomitant medications and adverse events (AEs)
Assist with set-up of data management study files and the collection, transfer, and archiving of study documentation and controlled documents
Maintains all the necessary documentation to support accuracy and integrity of clinical databases
Assist with the tracking of controlled documents (CRFs, data clarification forms [DCFs], etc.)
Assist in defining workflow and processes for all aspects of data management
Collaborate with management to develop and refine departmental SOPs relating to data management
Conduct and direct database development, testing, and validation
Conduct and direct training of clinical data associate (CDA) staff
Carry out all activities according to CTI SOPs and project-specific conventions within the framework of Quality Management and Good Clinical Practice (GCP) / ICH guidelines
Maintain accurate records of all work performed.

What You'll Bring:

At least 2 years clinical data management experience in any capacity
Experience with MediData Rave or OmniComm TrialMaster
Experience providing knowledge of ICH/GCP guidelines and applicable regulatory requirements
Bachelor’s Degree or equivalent in biological, behavioral, or computer science

About CTI

CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com

Why CTI?

Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.

Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.

Please Note

We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process

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