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 I

ILocation: Aliso Viejo, C

APay rate: $48/hr. on W

2Duration: 6 Months (Extension Possible

)Shift: 1st Shif

tMedical device clinical study experience strongly preferre

d
Position Overvi

• ewClient 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 deliverable
• s.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 environmen

ts
Key Responsibilit

• iesSupport authoring, review, and maintenance of Data Management documentation includi
• ng:Data Management Plans (D
• MP)Project Pl
• ansCRF Completion Guideli
• nesEdit Check Specificati
• onsData Review Guideli
• nesManage User Acceptance Testing (UAT) activities for EDC systems and clinical databa
• sesFacilitate cross-functional meetings with Clinical Study Teams, Project Managers, Programming, and Regulatory te
• amsOversee EDC study deliverables and database management activit
• iesLead and support data cleaning activities across clinical stud
• iesReview clinical data to identify trends, inconsistencies, outliers, and quality issues while generating/resolving quer
• iesProvide data metrics and status updates during study meeti
• ngsReview SAS and SDTM datasets to support data integrity and complia
• nceSupport external data reconciliation and third-party data review activit
• iesGenerate customized reports and listings for study teams and safety revi
• ewsSupport medical coding and AE/SAE reconciliation activit
• iesMaintain audit-ready project documentation and vendor fi
• lesMonitor enrollment metrics and provide updates to study te
• amsDevelop and support training materials for investigators, site staff, and internal te
• amsContribute to departmental process improvements and SOP developm

ent
Required Qualificat

• ions2–5 years of Clinical Data Management experi
• enceExperience within Pharmaceutical, Biotechnology, Medical Device, or CRO environments requ
• iredStrong understanding of FDA, ICH, and clinical data management regulat
• ionsHands-on experience with EDC platforms such
• as:Medidata
• RAVEOracle In
• formiMe
• dNetSimilar EDC sys
• temsExperience with database concepts and clinical data review t
• oolsStrong understanding of CDISC standards (CDASH, S
• DTM)Experience creating Data Management documentation including DMPs and edit check specificat
• ionsExperience with data review, query management, and reconciliation activi
• tiesStrong project coordination and organizational sk
• illsExcellent written and verbal communication sk
• illsExperience with SQL, SAS, Excel, or programming tools is a
• plusBS degree or higher in Biological Sciences, Nursing, or related healthcare discipline prefe

rred
Preferred Qualifica

• tionsOphthalmology clinical research experience pref
• erredMedical device clinical study experience strongly pref

erred
Top Skills / Ke

• ywordsClinical Data Mana
• gementEDC Systems (RAVE, Inform, iM
• edNet)UAT T
• estingData Cleaning & Vali
• dationCDISC Sta
• ndardsSDTM /
• CDASHSAS
• / SQLClinical Trial Documen
• tationRegulatory Comp
• lianceCross-Functional Collabo
• rationQuery Mana
• gementData Reconcil
• iationProject Coordi

nation
About Trident Con

sultingTrident 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 se

rvices.
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, a