drjobs Clinical Data Analyst

Clinical Data Analyst

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1 Vacancy
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Job Location drjobs

Irvine - USA

Monthly Salary drjobs

Not Disclosed

drjobs

Salary Not Disclosed

Vacancy

1 Vacancy

Job Description

Responsibilities:
  • The main function of a clinical data analyst is to create moderately complex metrics to identify trends in data and remediation utilizing tools (e.g. systems reports) to assess the need for training and provide basic recommendations to improve data status during study conduct.
  • Evaluate data errors and collection issues; provide guidance and recommendations to the clinical team for resolution.
  • Define and specify clinically data collection requirements (e.g. eCRFs CRFs edit checks and collection of external data) for assigned studies including defining performing and coordinating user acceptance testing (e.g. test scripts and checklists) to ensure appropriate data are collected.
  • Lead project management activities for a cohort or project to bring clinical studies online including conducting project team meetings establishing and maintaining project timelines and communicating with stakeholders.
  • Maintain and develop assigned sections of Data Management deliverables including data management plans (DMPs) training materials and user aids in compliance with regulations 10.
  • Perform Site/User Administration to allow access to the database ensuring all users are qualified to access the data database.
  • Participate in the development and review of SOPs work instructions and associated documents for CDM including recommending revisions and updates to SOPs participating in the development of user training.
  • Manage/Support Clinical Data management activities for a study.
  • Experience with Electronic Data Capture (EDC) platforms (medidata Rave Oracle Clinical) data programming tools and/ data reviewing tools (SAS).
  • Works closely with internal Data Management supporting all data management activities for studies (to include database setup CRF design and validation edit checks ongoing data review data reconciliation critical data review document archival Data lock activities etc.
  • Reports status provides metrics to inhouse Data Manager Interactions with data management personnel on assigned activities and deliverable.
Requirements:
  • Bachelors Degree or equivalent.
  • 24 years of experience required.
  • Medidata Rave EDC database updates/migrations data review query management etc.
  • Data management experience support lead on a study Medidata RAV EDC database experience.
  • Experience with EDC (Electronic Data Capture) systems required.
  • Good computer skills in Microsoft Office Suite.
  • Good written and verbal communication skills and interpersonal relationship skills.
  • Good problemsolving and critical thinking skills.
  • Good communication and presentation skills.
  • Medidata Rave experience Data review Query management Excel Reports.
  • Communication skills lead/ colead a study.
  • Not having Medidata RAVE EDC experience 2.
  • Analysis Skills.
  • Case Report Form (CRF) Clinical Assessment Clinical Data Clinical Data Management Clinical Support Clinical Trial Communication Skills.
  • Contract Analysis Data Analysis Data Collection Data Management Data Migration Data Quality Database Administration Database Technology Document Archiving Electronic Data Capture (EDC) Interpersonal Skills Leadership Metrics Oracle People Management Presentation/Verbal Skills Programming Tools Project/Program Management.
  • Reconciliation Regulatory Compliance Standard Operating Procedures (SOP) Status Reports Trend Analysis Validation Testing Writing Skills.

Employment Type

Full Time

Company Industry

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