EDC Systems: Practical experience working with industry-leading EDC platforms (e.g., Medidata Rave, Veeva Vault CDMS, RedCap, or Oracle InForm). Collaborate cross-functionally with Clinical Operations, Biostatistics, Quality Assurance, and Site Management teams to achieve trial milestones on schedule.
Numbers & Facts
Location
Tucson, AZ
Description
Our Client, a Biotech company, is looking for a Clinical Data Manager II for their Tucson, AZ/Hybrid location.
Responsibilities:
Data Management & Database Development
Oversee data collection, cleaning, and validation activities across assigned clinical trials to ensure high data quality, accuracy, and completeness.
Participate in the design, development, and testing of Electronic Data Capture (EDC) systems, user acceptance testing (UAT), and data validation specifications.
Manage query generation, reconciliation, and resolution workflows, working closely with clinical trial sites and CRO partners.
Technical Scripting & Workflow Automation
Develop and execute custom Python scripts and software utilities to automate data extraction, validation, routine cleaning checks, and metrics reporting.
Evaluate trial data infrastructure to identify technical bottlenecks, implementing software solutions that enhance processing speed and data accuracy.
Partner with technical and biostatistics teams to streamline data transformations and standardizations (e.g., CDISC SDTM/CDASH).
Ensure all clinical data management activities strictly adhere to Good Clinical Practice (GCP), ICH guidelines, FDA regulations, and standard operating procedures (SOPs).
Prepare, maintain, and review clinical data management documentation for regulatory inspections and quality audits.
Collaborate cross-functionally with Clinical Operations, Biostatistics, Quality Assurance, and Site Management teams to achieve trial milestones on schedule.
Requirements:
Bachelor's Degree in Life Sciences, Computer Science, Health Informatics, Data Science, or a related field. Master's degree is a plus.
Professional Experience: Minimum of 2+ years of clinical data management experience within clinical trials (0-5 years total professional experience).
Technical Competencies
Technical Scripting:
Advanced hands-on proficiency in Python for script automation, data manipulation, and software integration. Familiarity with additional programming languages (e.g., SQL, R, or SAS) is strongly desired.
EDC Systems:
Practical experience working with industry-leading EDC platforms (e.g., Medidata Rave, Veeva Vault CDMS, RedCap, or Oracle InForm).
Regulatory Knowledge:
Solid understanding of GCP standards, 21 CFR Part 11, and regulatory audit readiness expectations.
Soft Skills & Core Attributes
Initiative & Drive:
Self-motivated mindset with a strong track record of taking ownership of projects and driving results independently.
Problem-Solving:
Strong analytical capabilities with meticulous attention to detail in high-volume, complex data environments.
Collaboration & Communication:
Excellent written and verbal communication skills; ability to articulate technical data solutions clearly to non-technical stakeholders