Lab Clinical Data Analyst Job in overland park 66062, Kansas US
Quintiles pioneered the idea of helping pharma companies conduct objective clinical trials to establish not only whether a drug is effective, but who can take it safely.
Our customers have relied on us to design and conduct rigorous clinical research for decades, from small studies to multinational mega-trials.
However, we continue to develop new ways of interpreting and evaluating data that allow us to create more effective trials and determine outcomes faster.
If that is your passion, we have a place for you. Office or Home-Based Position Provide solid core and some comprehensive data management expertise to Data Management to provide efficient, quality data management products that meet customer needs.
Provide leadership to the team in the area of Lab Data Management, external data processing and cleaning.
RESPONSIBILITIES
Serves as the primary contact with the client or Data Management Team Lead during the data transmission phase of the clinical trial.
Responsible for global studies.
Communicates with both internal and external customers to ensure that the timelines are met, and to ensure that data is delivered following company guidelines and regulatory compliance
Initiates and performs quality control tasks for processing incoming and outgoing data files.
Works with programmers to update the programming when required while documenting all changes.
Ensures that the data transfer specifications are correct by working with the computer validators by performing user acceptance testing and sign-off.
Researches and resolves issues on error logs.
Reviews own work for accuracy and completeness.
Resolve issues related to missing ranges, units, conversions, and incorrect ranges / conversions.
Resolve issues related to incorrect / missing data, out of range / out of life data, and duplicate data
Obtains peer-review quality check of data files before transmission.
Performs peer-review quality checks for co-workers' data files.
Communicates with designated data recipients to assure that requirements are being met and questions answered.
Escalates issues to the Data Management Team Lead data management Manager as necessary.
Provides regular status reports to management including missed timelines and unscheduled transmissions.
Review lab data on a specified schedule and identify issues and inconsistencies (missing information, incorrect information, abnormal or unusual information.
A bachelor's degree in Laboratory sciences, Microbiology, or Biotechnology with minimum 2-3 years of experience processing lab data for clinical trials preferably in OC and RAVE system Minimum 3 years experience in managing study level projectsThorough understanding of physiology, pharmacology, clinical study objectives and methodologies; Scientific and technical knowledge of lab data processing for clinical trials and how they apply to the review of clinical data.
Familiarity with clinical trial databases and applications Knowledge of OC and EDC sub-system desirableThorough knowledge of lab tests, results, ranges, and unit conversionsThorough understanding of how lab data integrates with the rest of the clinical study dataThorough understanding of GCP and / or GLP and ICHThorough understanding of Medical / Life Science in several therapeutic areasSolid experience and organizational, communication, and demonstrated expert data management skills.
Ability to work in a high volume and strict deadline environment Comprehensive understanding of clinical drug development process.
Must be detail oriented.
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