Clinical Data Coordinator Trainee

The Clinical Data Coordinator (CDC) is a key member of the Clinical Development Operations, Data Management Team. The Clinical Data Coordinator will provide data management support for all assigned studies. The CDC Prepares, validates, processes, and maintains clinical data in support of submissions to international regulatory agencies or publication of manuscripts. This will be accomplished with through the use of EDC and SAS software.

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  Assists in the development of edit specifications, based on any available global medical standards, therapeutic area standards, and the protocol, used to clean the study.

• Supports the coding schedule defined in the data management plan.

• Performs manual data listing reviews and submits queries as appropriate.

• Assists in determining when each patient has no more data quality issues, based on EDC, coding, and SAS based queries. Also, must coordinate and review medical and statistical queries and certify they are adequately resolved.

• Coordinates the query management system functions.

• Assists in performing final patient reviews and database lock activities.

• Assists in coordinating the processing of scheduled data transfers (PK/PD data, imaging data, laboratory data) from external vendors

• Performs relevant review/reconciliation of 3rd party data.

• Reviews query responses and ensures data quality.

• May draft or update documents for the data management plan.

• May assist with the SAE reconciliation process.

Education: Bachelor’s degree in related discipline and one year of related experience; or high school diploma.

Required Skills:

• Proficient with Microsoft Office Suite.

• Excellent written and oral communication skills.

• Strong organizational, problem-solving, and analytical skills.

• Ability to manage priorities and workflow.

• Versatility, flexibility, and a willingness to work within constantly changing priorities.

• Proven ability to handle multiple projects and meet deadlines.

• Strong interpersonal skills.

• Ability to deal effectively with a diversity of individuals at all organizational levels.

• Commitment to excellence and high standards.

• Creative, flexible, and innovative team player.

• Ability to work independently and as a member of various teams and committees.

• Good judgement with the ability to make timely and sound decisions.

. Ability to be discrete with sensitive company information.