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Clinical Data Manager
Peachtree BioResearch Solutions
full-time
Posted on:
Origin: • 🇺🇸 United States
Visit company websiteJob Level
Mid-LevelSenior
About the role
- Responsible for all data management activities associated with the acquisition, documentation, review, cleaning and processing of clinical data in clinical trials
- Relay information regarding data management status, knowledge regarding area of discipline, and timelines affecting Data Management deliverables as a member of the clinical study team
- Ensure the Case Report Form is designed according to the Clinical Protocol, utilizing Data Standards where possible, and document deviations if necessary
- Create the Data Management Plan, Data Cleaning Plan, Quality Control Plan, and Data Management Report ensuring consistency with the Clinical Trial Protocol and compliance with internal or sponsor procedures, regulations and Good Clinical Practices
- Project, plan, develop, implement and deliver quality results in a timely manner using facts, data, measurements and a systematic approach
- Interpret the Clinical Protocol to ensure the accurate and efficient design of the CRF
- Analyze metrics surrounding activities associated with acquisition, documentation, review, cleaning and processing of clinical data
- Interpret study timelines and prioritize workload appropriately
- Assist with Clinical Data Associate activities during times of peak workload
Requirements
- Clinical Data Management experience in a CRO
- Working knowledge of medical terminology, federal regulations, Good Clinical Practice, and Good Clinical Data Management Practices
- Excellent communication, organization, and problem solving skills
- Ability to work independently, as well as handle a number of diverse projects simultaneously, under tight time constraints
- Ability to engage and demonstrate cooperative behavior to support team efforts
- Experience in responding rapidly to changing priorities and in managing aggressive deadlines.
