Johnson & Johnson Careers

Associate Manager, Clinical Data Management

Shanghai, China
Clinical Data Management

Job Description

Requisition ID: 1805633232W

This is a professional individual contributor role that provides a study level data management CRO oversight and takes data management accountability for one or more low to moderate complexity trials.  Makes recommendations and influences decisions to trial processes in line with business needs and in support of Clinical Development and Medical Affaires clinical studies. Looks over DM CRO project timelines and ensures quality of DM deliverables by CRO DM. Oversees E2E processes for China MAF trials. Consults with internal clients on DM issues in trial set-up, trial conduct and database lock activities. Facilitates real-time inspection readiness of all China DM deliverables for clinical trial and works on archiving documents for trials. Participates in process, system and tool improvement initiatives within China DM and presents at investigator and monitor meetings if assigned. Works with Data Management Leader to facilitate compliance with regulatory guidelines. 
A. Education /Training background:   Bachelor/Master or above degree in a scientific discipline or health related field.  
B. Knowledge/Skills: Full understanding of relevant regulatory guidelines, GCP and international guidelines regarding data management. Understanding of the clinical drug development process in the pharmaceutical industry Experience with DM systems e.g. Medidata Rave, ClinTrial, InForm Understanding of current industry standards (CDISC, SDTM, CDASH...) and of technology platforms for data exchange. 
C.  Job experience: Requires >= 6 years of experience in data management and in clinical drug development in the            pharmaceutical industry.    
D. Competency:  Diligent and serious, precise thinking, strong sense of responsibility and accountability. Results and           performance driven, sense of urgency. Team spirit, attention to details and good self-awareness. 
E.  Others: Good written and great verbal communication skills in Chinese and English. Being able to give  presentations and actively participate in meetings in both Chinese and English. 

Primary Location
J&J (China) Investments Ltd (7046)
Job Function
Clinical Data Management
Requisition ID