Required skills
- Pharmaceutics
- Core Data
- Data Management
- Database
- Data Collection
- Data Quality
- Testing
- Acceptance Testing
- Data Validation
- Workflow
- Data Extraction
- Reporting
- CDISC
- SDTM
- Regulatory Compliance
- Good Clinical Practice
- Standard Operating Procedure
- Documentation
- Quality Audit
- Biostatistics
- Quality Assurance
- Management
- Life Sciences
- Computer Science
- Health Informatics
- Data Science
- Clinical Data Management
- Clinical Trials
- Scripting
- Python
- Data Manipulation
- System Integration
- Programming Languages
- SQL
- R
- SAS
- EDC
- Veeva
- CDMS
- Oracle
- Google Cloud
- Google Cloud Platform
- Auditing
- Problem Solving
- Conflict Resolution
- Analytical Skill
- Attention To Detail
- Collaboration
- Communication
- Articulate
- Privacy
- Artificial Intelligence
- Recruiting
- MEAN Stack
- Customer Service
- Training And Development
- SAP BASIS
Job description
Project overview
Software Guidance & Assistance, Inc., (SGA), is searching for a Clinical Data Manager II for a contract assignment with one of our premier Pharmaceutical clients in Tucson, AZ.
Responsibilities
Seeking a highly technical, proactive, and driven Clinical Data Manager 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.
Required Skills:
- 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 (Google Cloud Platform), 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.
- Bachelor's Degree in Life Sciences, Computer Science, Health Informatics, Data Science, or a related field.
- 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 Google Cloud Platform 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.
Nice to have
#LI-SM2
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SGA is a technology and resource solutions provider driven to stand out. We are a women-owned business. Our mission: to solve big IT problems with a more personal, boutique approach. Each year, we match consultants like you to more than 1,000 engagements. When we say let's work better together, we mean it. You'll join a diverse team built on these core values: customer service, employee development, and quality and integrity in everything we do. Be yourself, love what you do and find your passion at work. Please find us at .
SGA is an Equal Opportunity Employer and does not discriminate on the basis of Race, Color, Sex, Sexual Orientation, Gender Identity, Religion, National Origin, Disability, Veteran Status, Age, Marital Status, Pregnancy, Genetic Information, or Other Legally Protected Status. We are committed to providing access, equal opportunity, and reasonable accommodation for individuals with disabilities in employment, and our services, programs, and activities. Please visit our company to request an accommodation or assistance regarding our policy
Job Facts: Contract W2 | On-site | USD $40.00 - 55.00 per hour
Skills: Pharmaceutics, Core Data, Data Management, Database, Data Collection, Data Quality, Testing, Acceptance Testing, Data Validation, Workflow, Data Extraction, Reporting, CDISC, SDTM, Regulatory Compliance, Good Clinical Practice, Standard Operating Procedure, Documentation, Quality Audit, Biostatistics, Quality Assurance, Management, Life Sciences, Computer Science, Health Informatics, Data Science, Clinical Data Management, Clinical Trials, Scripting, Python, Data Manipulation, System Integration, Programming Languages, SQL, R, SAS, EDC, Veeva, CDMS, Oracle, Google Cloud, Google Cloud Platform, Auditing, Problem Solving, Conflict Resolution, Analytical Skill, Attention To Detail, Collaboration, Communication, Articulate, Privacy, Artificial Intelligence, Recruiting, MEAN Stack, Customer Service, Training And Development, SAP BASIS
Reference: Dice Id: sgainc | Position Id: 26-02865
- Master's degree is a plus.
Project details
- Start: flexible
- Remote: onsite
- Location: Tucson, AZ, US, US
- Rate: 40-55 EUR/h
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