PpJoin our global team dedicated to innovation and initiative, where physical walls and different time zones don’t limit, but encourage, collaboration. Where all contributions and new ideas are explored with an open mind and work is driven by our shared values: be courageous, be accountable, be honest, be inclusive and elevate others. /p h3Overview /h3 pJob Description /p h3Responsibilities /h3 ul liAccountable for achieving project milestones from study start up through to delivery of database and monitoring of time spent of tasks /li liDesign the Case Record Form and guide process for CRF approval /li liDefine and develop the Data Management Plan, Data Validation Plan and their annexes (e.g. Reconciliation Plan), with input from the study team /li liFor EDC studies, define the User Acceptance Test Plan (UAT) and execute the test activities in the test environment to ensure quality eCRF /li liFor EDC studies, timely response to issues identified by the eCRF Helpdesk /li liPrepare CRF completion guidelines /li liPrepare study specific data-entry guidelines and train data-entry staff /li liPerform term coding for clinical studies, raise manual queries for uncoded terms as required /li liQuery management: review discrepancies, review answered queries, resolve and close where appropriate, manage the data cleaning process including manual check and Medical Review listings /li liApply SOPs and guidance documents as well as applicable industry standards like ICH, GCP etc to day-to-day activities generating all the required documentation for study files /li liInput into and monitor progress against study project plan and escalate issues for resolution at the appropriate level /li liRun and monitor study data progress reports including query management and take appropriate actions (e.g. escalation, re-training, etc), escalate any study issues within study team /li liPerform timely data integration of CRF and non CRF data (data import from external sources) /li liPerform reconciliation of external data (e.g. SAE, Central Labs, ECGs, etc) /li liDefine and execute QC plan, lead and execute database release and database freeze/lock activities /li liPlan and prioritise their own work and take appropriate actions /li liConducts other activities as required /li /ul h3Desired Qualifications Experience /h3 ul liDegree in life science, pharmaceutical, biology or related field or at least 6 months experience in data management field or similar in a pharmaceutical environment or equivalent /li liBasic understanding of pharmaceutical industry guidelines like ICH, GCP etc /li liBasic understanding of Data Management processes /li /ul h3Technical Competences Soft Skills /h3 ul liEnglish, Fair /li liMS Office Suite, Good /li liProfessional /li liTrustworthy /li liAbility to effectively prioritize /li liQuality focused /li liPersonable Attitude /li liWillingness to learn /li liTeam Player /li /ul h3Contract Type /h3 pIntern (Fixed Term) (Trainee) /p /p #J-18808-Ljbffr