Sr. Clinical Data Associate/Reviewer
6 days ago
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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