Overview
On Site
Full Time
Skills
Data Cleansing
Data Management
Acceptance Testing
Reporting
EDC
Training
Clinical Research
Database
Auditing
Quality Control
Editing
Management
Dialog Manager
Dimensional Modeling
SAS Display Manager
Documentation
Science
Clinical Data Management
Leadership
Communication
Project Management
Job Details
Responsibilities:
- Lead the data management activities from study start-up through the entire data cleaning process until database lock to support the clinical studies.
- Oversee all project related data management activities and manage project resources and timelines to ensure deliverables and targets are met.
- Create data management plan, edit check document, and Case Report Form (CRF) completion guidelines.
- Perform user acceptance testing (UAT) for Electronic Data Capture (EDC) systems.
- Clean database by generating, reviewing, and closing query resolutions through daily Case Report Form review.
- Help site support to answer study-related questions and perform EDC training, as needed.
- Communicate with Clinical Research Associate (CRA), sponsor, and third-party vendors (such as central laboratory) to discuss study related functions.
- Perform AE/SAE (Adverse Event/Serious Adverse Event) and third-party data (such as Pharmacokinetic lab and safety lab) reconciliation.
- Communicate with other internal departments to maintain and track project timelines.
- Perform database audit, as needed, lock and clinical data archive.
- Perform quality control on various types of tasks, such as review edit check listings and manage DM documentation and study reports.
- Bachelor's degree in science or related field or equivalent defined as a minimum of 6 years related, combined experience in employment, education, knowledge, and skills that will enable the incumbent to proficiently perform the duties of the role is required.
- Minimum 6 years industry experience in clinical data management if bachelor's degree; Minimum 4 years industry experience in clinical data management if master's degree.
- Leadership experience gained leading projects or teams.
- Strong communication and project management skills.
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