Trident Consulting is seeking a " Clinical Data Manager” for one of our client in " Aliso Viejo, CA (Onsite)” A global leader in business and technology services.
Please find additional details about the role below:
Job Title: Clinical Data Manager
Location: Aliso Viejo, CA (Onsite)
Type of Hire: Contract
Pay rate: $45/hr to $48/hr on W2 (All inclusive)
Duration: 6+ Months (Possible Extension)
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
- Medidata
- 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.