Clinical Data Manager II

Trident Consulting is seeking a " Clinical Data Manager II " for one of our clients in "San Francisco, CA" A global leader in business and technology services.

Job Title: Clinical Data Manager II

Location: Aliso Viejo, CA

Pay rate: $29/hr. on W2

Duration: 6 Months (Extension Possible)

Shift: 1st Shift

Medical device clinical study experience strongly preferred

Position Overview

• Client is seeking a Clinical Data Manager II to support end-to-end clinical data management activities from study start-up through closeout. This role will focus on data cleaning strategies, database management, clinical data review, EDC oversight, and cross-functional collaboration to ensure high-quality, compliant clinical data deliverables.
• The ideal candidate will have strong project management, analytical, and communication skills with hands-on clinical data management experience within pharmaceutical, biotechnology, medical device, or CRO environments

Key Responsibilities

• Support authoring, review, and maintenance of Data Management documentation including:
• Data Management Plans (DMP)
• Project Plans
• CRF Completion Guidelines
• Edit Check Specifications
• Data Review Guidelines
• Manage User Acceptance Testing (UAT) activities for EDC systems and clinical databases
• Facilitate cross-functional meetings with Clinical Study Teams, Project Managers, Programming, and Regulatory teams
• Oversee EDC study deliverables and database management activities
• Lead and support data cleaning activities across clinical studies
• Review clinical data to identify trends, inconsistencies, outliers, and quality issues while generating/resolving queries
• Provide data metrics and status updates during study meetings
• Review SAS and SDTM datasets to support data integrity and compliance
• Support external data reconciliation and third-party data review activities
• Generate customized reports and listings for study teams and safety reviews
• Support medical coding and AE/SAE reconciliation activities
• Maintain audit-ready project documentation and vendor files
• Monitor enrollment metrics and provide updates to study teams
• Develop and support training materials for investigators, site staff, and internal teams
• Contribute to departmental process improvements and SOP development

Required Qualifications

• 2–5 years of Clinical Data Management experience
• Experience within Pharmaceutical, Biotechnology, Medical Device, or CRO environments required
• Strong understanding of FDA, ICH, and clinical data management regulations
• Hands-on experience with EDC platforms such as:
• Medidata RAVE
• Oracle Inform
• iMedNet
• Similar EDC systems
• Experience with database concepts and clinical data review tools
• Strong understanding of CDISC standards (CDASH, SDTM)
• Experience creating Data Management documentation including DMPs and edit check specifications
• Experience with data review, query management, and reconciliation activities
• Strong project coordination and organizational skills
• Excellent written and verbal communication skills
• Experience with SQL, SAS, Excel, or programming tools is a plus
• BS degree or higher in Biological Sciences, Nursing, or related healthcare discipline preferred

Preferred Qualifications

• Ophthalmology clinical research experience preferred
• Medical device clinical study experience strongly preferred

Top Skills / Keywords

• Clinical Data Management
• EDC Systems (RAVE, Inform, iMedNet)
• UAT Testing
• Data Cleaning & Validation
• CDISC Standards
• SDTM / CDASH
• SAS / SQL
• Clinical Trial Documentation
• Regulatory Compliance
• Cross-Functional Collaboration
• Query Management
• Data Reconciliation
• Project Coordination

About Trident Consulting

Trident Consulting is an award-winning staffing and consulting firm headquartered in San Ramon, CA. Since 2005, we’ve partnered with Fortune 500 and high-growth companies to deliver high-quality talent across technology, engineering, business operations, and professional services.

We specialize in contract, contract-to-hire, and direct hire placements, supporting roles across IT, data & analytics, cloud, cybersecurity, finance & accounting, HR, operations, and more. With a strong focus on hard-to-fill and niche positions, our global recruiting engine enables us to deliver speed, quality, and scale