Job Description
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
nd scale