Overview
Remote
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 16 day((s))
Skills
Business Analyst with Clinical Data
Job Details
Business Analyst Clinical Data Management Key Responsibilities
- Requirements Gathering & Documentation
- Analyze stakeholder needs and capture requirements in documents such as Business Requirements Documents (BRDs), Functional Requirements Specifications (FRS), user stories, and acceptance criteria.
- Translate business objectives into technical designs for systems like CTMS, eTMF, EDC, and RBQM.
- Clinical Data Management & Quality Assurance
- Develop and maintain data management plans, case report forms (CRFs), and validation rules.
- Lead data cleaning, discrepancy resolution, SAE reconciliation, interim/final database lock, and ensure data integrity across the trial lifecycle.
- System Testing & Validation
- Collaborate with QA/UAT teams; contribute to test planning, review test cases, and oversee validation of database components and edit checks.
- Stakeholder Communication & Training
- Liaise with clinical and technical teams to align on requirements, designs, and timelines, ensuring project scope is met.
- Train end-users on clinical systems, document SOPs, and support audit readiness.
- Reporting & Process Improvement
- Generate reports and dashboards on data quality, study progress, and compliance; recommend optimizations.
- Provide guidance on standards (e.g., Google Cloud Platform, CDISC, FDA) and contribute to data management SOP enhancements.
- Educational Background
- Bachelor's degree in Life Sciences, Healthcare, Computer Science, or a related field. Advanced degrees (e.g., Master's) preferred.
- Technical Proficiency
- Experience with electronic data capture systems (e.g., Medidata RAVE), SQL, and commonly used tools (SAS, Python, R).
- Skilled in documentation tools (JIRA, Confluence), BRD/FRS development, user story creation.
- Analytical & Communication Skills
- Strong analytical thinking, problem-solving, attention to detail, and ability to manage multiple priorities.
- Excellent written and verbal communication for clear stakeholder collaboration and training.
- Experience
- 3 5 years in clinical data management or related roles (e.g., Clinical Data Manager, Clinical Analyst).
- Exposure to audits, regulatory submissions, and cross-functional team environments.
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