Clinical Data Manager II

Position Title: Clinical Data Manager II

Work Location: Tucson AZ

Assignment Duration: 3 Years

Work Arrangement: Hybrid (minimum 3 days onsite each week)

Position Summary:

• We are seeking a highly technical, proactive, and driven Clinical Data Manager II to join our data management team. In this role, you will oversee end-to-end data collection and validation processes, design robust clinical databases, and maintain compliance across all clinical trials.
• Beyond core data management capabilities, the ideal candidate brings strong technical expertise in Python scripting and automated software tools to modernize clinical data workflows. You are a self-starter who takes the initiative to solve complex data challenges, streamlines query resolution, and collaborates seamlessly across cross-functional study teams.

Key Responsibilities:

• 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.
• 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.

Qualification & Experience:

• Education: 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 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.
• 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.