Clinical Data Manager II

Cynet Systems • Tucson, AZ

2d

About The Position

The Clinical Data Manager II will oversee end-to-end data collection and validation processes, design clinical databases, and support compliance across clinical trials. The role combines clinical data management expertise with advanced Python scripting and automated software tools to modernize data workflows. The successful candidate will proactively solve complex data challenges, streamline query resolution, and collaborate with cross-functional study teams.

Responsibilities include managing data collection, cleaning, validation, and query workflows; contributing to EDC system design, development, testing, and validation specifications; and building Python scripts and utilities to automate data extraction, checks, cleaning, and metrics reporting. The role also involves identifying infrastructure bottlenecks, supporting data transformations and standards, maintaining regulatory compliance and inspection-ready documentation, and working with clinical and technical teams to meet study milestones.

Requirements

• Bachelor's degree in Life Sciences, Computer Science, Health Informatics, Data Science, or a related field.
• At least 2 years of clinical data management experience within clinical trials.
• Advanced hands-on proficiency in Python for script automation, data manipulation, and software integration.
• Practical experience with industry-leading EDC platforms such as Medidata Rave, Veeva Vault CDMS, REDCap, or Oracle InForm.
• Solid understanding of GCP standards, 21 CFR Part 11, and regulatory audit-readiness expectations.
• Strong analytical and problem-solving capabilities, with meticulous attention to detail in high-volume, complex data environments.
• Strong verbal and written communication skills, including the ability to explain technical data solutions clearly to stakeholders.
• Self-motivated, proactive approach with the ability to take ownership and drive results independently.

Nice To Haves

• Master's degree.
• Familiarity with SQL, R, or SAS.

Responsibilities

• Oversee data collection, cleaning, and validation across assigned clinical trials to ensure 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 in coordination with clinical trial sites and CRO partners.
• Develop and execute Python scripts and software utilities to automate data extraction, validation, routine cleaning checks, and metrics reporting.
• Evaluate clinical trial data infrastructure for technical bottlenecks and implement software solutions to improve processing speed and data accuracy.
• Partner with technical and biostatistics teams to streamline data transformations and standardizations, including CDISC SDTM/CDASH.
• Ensure clinical data management activities comply with 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 with Clinical Operations, Biostatistics, Quality Assurance, and Site Management teams to achieve trial milestones on schedule.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level