Clinical Data Manager II
Job ID: ROCGJP00044051
Client: Roche / Ventana Medical Systems
Location: Tucson, AZ (Hybrid - Minimum 3 Days Onsite Weekly)
Duration: Long-Term Contract
Pay Rate: $40-$55/hr (DOE)
Role Overview
We are seeking an experienced Clinical Data Manager II to support end-to-end clinical data management activities across multiple clinical trials. This role requires a strong combination of clinical data management expertise, regulatory knowledge, and technical proficiency in Python-based workflow automation.
The ideal candidate will be responsible for managing data collection, validation, database development, query resolution, and compliance activities while leveraging automation to improve clinical data quality and operational efficiency. This position offers the opportunity to collaborate closely with Clinical Operations, Biostatistics, Quality Assurance, CRO partners, and technical teams.
Key Responsibilities
Clinical Data Management & Database Development
- Oversee data collection, cleaning, validation, and reconciliation activities for clinical trials.
- Ensure data quality, completeness, and accuracy throughout the study lifecycle.
- Participate in the design, development, and testing of Electronic Data Capture (EDC) systems.
- Develop and execute User Acceptance Testing (UAT) protocols and validation specifications.
- Manage clinical data queries and coordinate resolution with trial sites and CRO partners.
Technical Scripting & Workflow Automation
- Develop and maintain Python scripts to automate data extraction, validation, reporting, and routine cleaning activities.
- Identify opportunities to streamline clinical data workflows and improve operational efficiency through automation.
- Collaborate with technical and biostatistics teams to support data transformation and standardization efforts.
- Support implementation and adherence to CDISC standards, including SDTM and CDASH.
Compliance, Audits & Cross-Functional Collaboration
- Ensure compliance with:
- Good Clinical Practice (GCP)
- ICH Guidelines
- FDA Regulations
- 21 CFR Part 11
- Internal SOPs
- Prepare and maintain clinical data management documentation for audits and regulatory inspections.
- Partner with Clinical Operations, Biostatistics, Quality Assurance, and Site Management teams to achieve study milestones and deliverables.
- Support audit readiness and quality management initiatives.
Share your resume at aditya.singh3@artech.com