Pp2 weeks ago Be among the first 25 applicants /ppGet AI-powered advice on this job and more exclusive features. /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. /ppbJob Description Summary /b /ppbJob Description /b /ph3Overview /h3pROLE /ppbThe Principal Database Programmer Role Involves The Following Characteristics /b /pulliLead and drive the DBP team, acting as mentor and coach /liliContribute to develop the clinical database to collect the clinical data provided on paper or electronic CRFs /liliProgram the computerized checks or SAS checks to ensure clean, accurate and complete clinical data can be delivered to customers /liliAct as the reference point for the Lead Data Manager and study Project Manager from the Database Programming perspective, ensuring DBP tasks for the assigned studies are performed on time and within budget /liliMake recommendation for process improvement and/or new standards development /liliEffective input into strategic planning across the department /liliBridge scientific or medical knowledge into database programming processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets /li /ulh3Key Responsibilities /h3ulliAccountable for driving achievement of project milestones from study start up through to delivery of database and monitoring of time spent on tasks /liliProvide Database Programming input into the protocol data collection assessments /liliCreate the annotated CRF (aCRF) using company standards or Sponsor’s naming conventions in accordance to relevant company procedures /liliAccountable for building of the clinical database, creating variables, codelists, forms and visits in accordance with the aCRF /liliDevelop the computerized checks in accordance with the Data Validation Plan /liliDevelop SAS checks in accordance with the Data Validation Plan /liliImplement mid study changes to the production eCRF when requested by the Lead DM /liliCommunicate the database setup status and the achievement of milestones to the Lead DM /liliCreate and validate import programs of electronic data received from external vendors /liliImport electronic data received from external vendors during the course of the clinical study /liliProgram and validate data listings (e.g. Manual checks, Medical Review listings, Coding report etc) /liliProgram and validate tracking or metric reports /liliPlan and prioritise his/her own work and take appropriate actions (e.g. escalation) /liliContribute in formal training for new database programming staff /liliApply 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 /liliLead the DBP team, coordinate other DBP staff providing direction regarding work assignment, scheduling and prioritizing; monitor progress of activities /liliMaintain continuous and appropriate communication with Lead DM and/or study Project Manager and share critical and general issues /liliDevelop and maintain a network of contacts within the study team /liliMake recommendations for database setup process improvements and development of new standards /liliInput into and monitor progress against study project plan and escalate issues to resolution at the appropriate level /liliProven ability to analyse data capture problems/opportunities and a track record of developing and delivering high quality solutions /liliDemonstrate broad and integrated knowledge of all aspects of Database Programming providing consultancy to other groups outside DBP /liliEducate/train on use of study specific data collection tool(s) /liliMake recommendations for process improvements and development of new standards /liliEffectively represents Database Programming in internal or external meetings (e.g. EDC demos) /liliConduct other activities as required /li /ulh3Qualifications /h3ulliExpert on Merative Zelta build and/or Medidata Rave build, certification of study builder will be an added value /liliDegree (preferably in Computer Science) or at least 6 years of experience in database programming field or similar in a pharmaceutical environment or equivalent /liliKnowledge of Alira Health systems, Very Good /liliKnowledge of Data Management processes, Very Good /liliKnowledge of pharmaceutical industry guidelines like ICH, GCP etc, Very Good /liliExpert in one or more clinical data management systems and recognized for expertise /liliKnowledge of SAS programming, Very Good /li /ulh3Technical Competences Soft Skills /h3ulliEnglish, Good /liliMS Office Suite, Good /liliProfessional /liliTrustworthy /liliAbility to effectively prioritize /liliQuality focused /liliPersonable Attitude /liliWillingness to learn /liliTeam Player /liliEffective Stress Management Techniques /liliLearning Agility /liliAbility to Manage Conflict /liliProblem Solving Skills /liliEffective Verbal Communication Skills /liliCommercial and Technical Writing Skills /liliNetworking Skills /liliAnalytical thinking /liliResilient /liliAbility to Influence and motivate /liliAbility to manage difficult conversations /liliInnovative /liliAbility to Provide Constructive Feedback /liliExcellent Presentation Skills /liliCommercial awareness /liliAbility to recognize and develop talent /li /ulh3Languages /h3pEnglish /ph3Education /h3pBachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): Pharmacy /ph3Contract Type /h3pHourly /ph3Seniority level /h3ulliMid-Senior level /li /ulh3Employment type /h3ulliFull-time /li /ulh3Job function /h3ulliInformation Technology /liliIndustries /liliPharmaceutical Manufacturing /li /ul /p #J-18808-Ljbffr