Sr. Clinical Data Associate / Reviewer - Medical Device / Biotechnology
Planet PharmaIrvine, CA, United States
6 days ago
Job type
Full-time
Job description
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.