Clinical Trial Data Manager

Trident Consulting is currently seeking a Clinical Trial Data Manager for one of our industry leading clients.

Role: Clinical Trial Data Manage

rLocation: Irvine, CA - Onsit

eDuration: 6 Month

sShift: 1st Shif

tEmployment Type: Temporary / Contrac

tPay: $46/hr - $48/hr on W2(Inclusive all

)
Position Summa

ryClient is seeking an experienced Clinical Data Manager II to support clinical study data management activities from study startup through study closeout. This role will be responsible for ensuring the quality, integrity, and compliance of clinical trial data while collaborating closely with cross-functional clinical teams. The ideal candidate will have hands-on experience in clinical data management, EDC systems, data review, and regulatory compliance within pharmaceutical, biotechnology, medical device, or CRO environment

s.Key Responsibiliti

• esAuthor, review, and maintain Data Management documentation, includin
• g:Data Management Plans (DMP
• s)Project Pla
• nsCRF Completion Guidelin
• esEdit Check Specificatio
• nsData Review Guidelin
• esCoordinate and execute User Acceptance Testing (UAT) activities for clinical databases and EDC system
• s.Facilitate Data Management meetings with Clinical Operations, Project Management, Programming, Regulatory Affairs, and Study Team
• s.Manage EDC study deliverables and support database management activitie
• s.Lead ongoing data cleaning and query management effort
• s.Review clinical data for trends, inconsistencies, quality issues, and outlier
• s.Generate, track, and resolve data querie
• s.Provide study data status updates, metrics, and reporting to stakeholder
• s.Review SAS and SDTM datasets to ensure data quality and regulatory complianc
• e.Support external data reconciliation and third-party vendor data revie
• w.Collaborate with programming teams to create custom reports, listings, and data review output
• s.Support medical coding and AE/SAE reconciliation activitie
• s.Maintain audit-ready Data Management documentatio
• n.Monitor study enrollment and provide enrollment metric
• s.Assist in developing training materials for investigators, clinical sites, and internal team
• s.Contribute to process improvements, SOP development, and best practices within Data Managemen

t.Required Qualificatio

• ns2–5 years of Clinical Data Management experienc
• e.Experience within Pharmaceutical, Biotechnology, Medical Device, or CRO environment
• s.Strong knowledge of FDA, ICH-GCP, and clinical data management regulations and guideline
• s.Hands-on experience with Electronic Data Capture (EDC) systems such a
• s:Medidata RA
• VEOracle Info
• rmiMedN
• etSimilar EDC platfor
• msExperience with clinical database design concepts and data review tool
• s.Knowledge of CDISC standards including CDASH and SDT
• M.Experience writing and maintaining Data Management documentatio
• n.Experience with data review, query management, and reconciliation processe
• s.Strong project coordination, organizational, and analytical skill
• s.Excellent verbal and written communication skill
• s.Experience with SAS, SQL, Excel, or related data analysis tools is a plu
• s.Bachelor's degree or higher in Biological Sciences, Nursing, Healthcare, or a related discipline preferre

d.Preferred Qualificatio

• nsOphthalmology clinical research experienc
• e.Medical device clinical trial experienc
• e.Experience supporting regulatory submissions and inspection readiness activitie

s.Required Skil

• lsClinical Data Manageme
• ntElectronic Data Capture (EDC) Syste
• msMedidata RAVE / Oracle Inform / iMedN
• etUAT Testi
• ngData Cleaning & Validati
• onQuery Manageme
• ntCDISC Standards (CDASH, SDT
• M)SAS and S
• QLClinical Trial Documentati
• onRegulatory Compliance (FDA, ICH-GC
• P)Medical Coding & Reconciliati
• onCross-Functional Collaborati
• onProject Coordination & Reporti