Sr. Clinical Data Associate/Reviewer

3 days ago


Irvine, United States Planet Pharma Full time

Job ID#: 616277


Our client, a mid-sized medical/biotech company, is seeking a Clinical Data Associate to join their growing team. This role is heavily focuses on resolving queries and data cleaning/review, and is perfect for someone with 5+ years in a medical device/biotech/CRO setting working with clinical trial data. See below for other details


***Please Note: This is an onsite position, no exceptions - Do not apply if you cannot commute daily***


Job Summary:

  • Creates the data cleaning strategy and leads the data cleaning efforts supporting Clinical Studies.
  • Lead and perform regular data review across studies to identify quality issues, data trends/outliers and generate queries as necessary.
  • Review and reconcile data from external sources. Database Build and User Acceptance Testing (UAT): Assist with the creation of the CRF and Edit Check Specifications documents. Perform User Acceptance Testing (UAT) of clinical databases including EDC.
  • EDC User Management: Manage EDC User Access for all assigned studies.
  • Collaboration with Cross-Functional Teams: Provide ongoing day-to-day support to the Clinical Study Teams to ensure all data is reviewed and discrepancies are resolved.
  • Collaborate with internal team and stakeholders to ensure deliverables meet timelines.
  • Work with Clinical Programming to produce additional reports outside of the Data Review Guidelines to facilitate efficient data review and cleaning.
  • Facilitate cross-functional Data Management meetings and discussions with Study Managers, Clinical Study Teams, Project Managers, Programming and Regulatory.
  • Generate reports or data listings for study teams as needed.
  • Review Protocol and provide feedback to the Clinical Study Team on data collection related items.
  • Process Improvement: Participate in the review and update of the Data Management standard operating procedures, work instructions, and templates.
  • Participate in the development of departmental processes and procedures.
  • Works in coordination with Data Management, Biostatistics and Clinical Operations teams to develop standard operating processes in support of clinical research.
  • Represent Data Management in study team meetings, providing data status metrics and providing guidance on issues related to data management.
  • Responsible for study Data Management activities from study start up to close out.
  • Author Data Management timelines for assigned studies.
  • Manage performance, quality, and timeliness of data from service providers (e.g., Central Reading Centers, Labs, Medical Coders).
  • Data Management Documents: Author Data Management documentation (e.g. Data Management Plans, Data Review Guidelines and eCRF Completion Guidelines, and Study Timelines, etc.) Author Data Management training materials used for Investigator Meetings, in-house personnel, and site staff.
  • Maintain Data Management project documentation including vendor files in an audit- ready manner.
  • Assist the Lead Clinical Programmers with the creation and maintenance of Data Transfer Agreements.


Requirements:

  • 5-10 years of clinical data review experience
  • Education: Associate's or Bachelor's Degree


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