Clinical Data Manager II

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).
• Compliance, Audits & Cross-Functional Collaboration
• 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

Why Should You Apply?

• Health Benefits
• Referral Program
• Excellent growth and advancement opportunities