Job Description
Our Client, a Biotech company, is looking for a Clinical Data Manager II for their Tucson, AZ/Hybrid location.
Responsibilities:
Requirements:
Why Should You Apply?
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
Numbers & Facts
| Location | Tucson, AZ |
| Industry | Management Consulting Services |
| Salary | $45.93–$88.70 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | https://www.iconma.com/ |
Benefits
401K, Employee Referral Program, Life Insurance
About Company
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
Skills
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