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Principal Database Programmer
7 ore fa
Principal Database Programmer role at Alira HealthJob Description SummaryThe Principal Database Programmer will lead and mentor the database programming team, ensuring high‑quality clinical databases that adhere to industry standards and project requirements.Role CharacteristicsLead and drive the DBP team, acting as mentor and coachContribute to developing the clinical database to collect the clinical data provided on paper or electronic CRFsProgram the computerized checks or SAS checks to ensure clean, accurate and complete clinical data can be delivered to customersAct 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 budgetMake recommendations for process improvement and/or new standards developmentProvide effective input into strategic planning across the departmentBridge scientific generalized knowledge into database programming processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasetsKey ResponsibilitiesAccountable for driving achievement of project milestones from study start‑up through to delivery of database and monitoring time spent on tasksProvide Database Programming input into the protocol data collection assessmentsCreate the annotated CRF (aCRF) using company standards or Sponsor’s naming conventions according to relevant company proceduresAccountable for building the clinical database, creating variables, codelists, forms and visits in accordance with the aCRFDevelop computerized checks in accordance with the Data Validation PlanDevelop SAS checks in accordance with the Data Validation PlanImplement mid‑study changes to the production eCRF when requested by the Lead DMCommunicate the database setup status and the achievement of milestones to the Lead DMCreate and validate import programs of electronic data received from external vendorsImport electronic data received from external vendors during the course of the clinical studyProgram and validate data listings (e.g., Manual checks, Medical Review listings, Coding reports, etc.)Program and validate tracking or metric reportsPlan and prioritise own work and take appropriate actions (e.g., escalation)Contribute to formal training for new database programming staffApply 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 filesLead the DBP team, coordinate other DBP staff, providing direction regarding work assignment, scheduling and prioritizing; monitor progress of activitiesMaintain continuous and appropriate communication with Lead DM and/or study Project Manager and share critical and general issuesDevelop and maintain a network of contacts within the study teamMake recommendations for database setup process improvements and development of new standardsInput into and monitor progress against study project plan and escalate issues to resolution at the appropriate levelProven ability to analyze data capture problems/opportunities and a track record of developing and delivering high‑quality solutionsDemonstrate broad and integrated knowledge of all aspects of Database Programming, providing consultancy to other groups outside DBP(etl omitted for brevity)Desired Qualification & ExperienceExpert on Merative Zelta build and/or Medidata Rave build; certification of study builder will be an added valueDegree (preferably in Computer Science) or at least six years of experience in database programming field or similar in a pharmaceutical environment or equivalentKnowledge of Alira Health systems stresifying Very GoodKnowledge of Data Management processes Very GoodKnowledge of pharmaceutical industry guidelines like ICH, GCP, etc. Very GoodExpert in one or more clinical data management systems and recognized for expertiseKnowledge of SAS programming Very GoodTechnical Competencies & Soft SkillsEnglish Bonnie goodMS Office Suite GoodProfessionalTrustworthyAbility to effectively prioritizeQuality focusedPersonable AttitudeWillingness to learnTeam PlayerEffective Stress Management TechniquesLearning AgilityAbility to Manage ConflictProblem Solving SkillsEffective Verbal Communication SkillsCommercial and Technical Writing SkillsNetworking SkillsAnalytical thinkingResilientAbility to Influence and motivateAbility to manage difficult conversationsInnovativeAbility to Provide Constructive FeedbackExcellent Presentation SkillsCommercial awarenessAbility to recognize and develop talentLanguagesEnglishицеเข้ÇEducationBachelor of Science (BS): BiologyBachelor of Science (BS): Life SciencesBachelor of Science (BS): PharmacyContract TypeHourlySeniority levelMid-Senior levelEmployment typeFull‑timeJob functionInformation TechnologyIndustriesPharmaceutical Manufacturing#J-18808-Ljbffr
