Principal Database Programmer

Principal Database ProgrammerThe Principal Database Programmer role involves the following characteristics:Lead and drive the DBP team, acting as mentor and coachContribute to develop 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 Database Programming perspective, ensuring DBP tasks for the assigned studies are performed on time and within budgetMake recommendation for process improvement and/or new standards developmentEffective input into strategic planning across the departmentBridge scientific or medical 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 of 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 in accordance to relevant company proceduresAccountable for building of the clinical database, creating variables, codelists, forms and visits in accordance with the aCRFDevelop the 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 report etc)Program and validate tracking or metric reportsPlan and prioritise his/her own work and take appropriate actions (e.g. escalation)Contribute in 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 the 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 analyse 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 DBPEducate/train on use of study specific data collection tool(s)Make recommendations for process improvements and development of new standardsEffectively represents Database Programming in internal or external meetings (e.g.

EDC demos)Conduct other activities as requiredDesired 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 6 years of experience in database programming field or similar in a pharmaceutical environment or equivalentKnowledge of Alira Health systems, 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 Competences & Soft SkillsEnglish, 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 talentLanguagesEnglishEducationBachelor of Science (BS): Biology, Bachelor of Science (BS): Life Sciences, Bachelor of Science (BS): PharmacyContract TypeHourly