PpbPrincipal Database Programmer /b role at bAlira Health /b /p h3Job Description Summary /h3 pThe Principal Database Programmer will lead and mentor the database programming team, ensuring high‑quality clinical databases that adhere to industry standards and project requirements. /p h3Role Characteristics /h3 ul liLead and drive the DBP team, acting as mentor and coach /li liContribute to developing the clinical database to collect the clinical data provided on paper or electronic CRFs /li liProgram the computerized checks or SAS checks to ensure clean, accurate and complete clinical data can be delivered to customers /li liAct as the reference point for the Lead Data Manager and study Project Manager from the DatabaseहाँProgramming perspective, ensuring DBP tasks for the assigned studies are performed on time and within budget /li liMake recommendations for process improvement and/or new standards development /li liProvide effective input into strategic planning across the department /li liBridge scientific generalized knowledge into database programming processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets /li /ul h3Key Responsibilities /h3 ul liAccountable for driving achievement of project milestones from study start‑up through to delivery of database and monitoring time spent on tasks /li liProvide Database Programming input into the protocol data collection assessments /li liCreate the annotated CRF (aCRF) using company standards or Sponsor’s naming conventions according to relevant company procedures /li liAccountable for building the clinical database, creating variables, codelists, forms and visits in accordance with the aCRF /li liDevelop computerized checks in accordance with the Data Validation Plan /li liDevelop SAS checks in accordance with the Data Validation Plan /li liImplement mid‑study changes to the production eCRF when requested by the Lead DM /li liCommunicate the database setup status and the achievement of milestones to the Lead DM /li liCreate and validate import programs of electronic data received from external vendors /li liImport electronic data received from external vendors during the course of the clinical study /li liProgram and validate data listings (e.g., Manual checks, Medical Review listings, Coding reports, etc.) /li liProgram and validate tracking or metric reports /li liPlan and prioritise own work and take appropriate actions (e.g., escalation) /li liContribute to formal training for new database programming staff /li liApply SOPs and guidance documents as well as applicable industry standards like ICH, GCP, etc. to day‑to‑day activities, generating all required documentation for study files /li liLead the DBP team, coordinate other DBP staff, providing direction regarding work assignment, scheduling and prioritizing; monitor progress of activities /li liMaintain continuous and appropriate communication with Lead DM and/or study Project Manager and share critical and general issues /li liDevelop and maintain a network of contacts within the study team /li liMake recommendations for database setup process improvements and development of new standards /li liInput into and monitor progress against study project plan and escalate issues to resolution at the appropriate level /li liProven ability to analyze data capture problems/opportunities and a track record of developing and delivering high‑quality solutions /li liDemonstrate broad and integrated knowledge of all aspects of Database Programming, providing consultancy to other groups outside DBP /li (etl omitted for brevity) /ul h3Desired Qualification Experience /h3 ul liExpert on Merative Zelta build and/or Medidata Rave build; certification of study builder will be an added value /li liDegree (preferably in Computer Science) or at least six years of experience in database programming field or similar in a pharmaceutical environment or equivalent /li liKnowledge of Alira Health systems stresifying Very Good /li liKnowledge of Data Management processes Very Good /li liKnowledge of pharmaceutical industry guidelines like ICH, GCP, etc. Very Good /li liExpert in one or more clinical data management systems and recognized for expertise /li liKnowledge of SAS programming Very Good /li /ul h3Technical Competencies Soft Skills /h3 ul liEnglish Bonnie good /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 liEffective Stress Management Techniques /li liLearning Agility /li liAbility to Manage Conflict /li liProblem Solving Skills /li liEffective Verbal Communication Skills /li liCommercial and Technical Writing Skills /li liNetworking Skills /li liAnalytical thinking /li liResilient /li liAbility to Influence and motivate /li liAbility to manage difficult conversations /li liInnovative /li liAbility to Provide Constructive Feedback /li liExcellent Presentation Skills /li liCommercial awareness /li liAbility to recognize and develop talent /li /ul h3Languages /h3 pEnglish /p ицеเข้Ç h3Education /h3 ul liBachelor of Science (BS): Biology /li liBachelor of Science (BS): Life Sciences /li liBachelor of Science (BS): Pharmacy /li /ul h3Contract Type /h3 pHourly /p h3Seniority level /h3 pMid-Senior level /p h3Employment type /h3 pFull‑time /p h3Job function /h3 pInformation Technology /p h3Industries /h3 pPharmaceutical Manufacturing /p /p #J-18808-Ljbffr