Clinical Data Manager II

Job Title: Clinical Data Manager II Location: Oro Valley, AZ Type: Contract - Long Term Compensation: $40 - $55/hr - Commensurate with level of experience Work Model: Hybrid - (minimum 3 days onsite each week) Please W2 candidates only - we cannot work C2C

Overview

Exciting opportunity for a skilled Clinical Data Manager to suppose clinical studies within a leading life sciences organization, with a focus on high quality clinical data, study execution, and cross functional collaboration.

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.

Requirements

• Education: Bachelors 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.

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

Ref: #568-Clinical