Principal Database Programmer

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ph3Responsibilities /h3ulliAccountable for driving achievement of project milestones from study start‑up through to delivery of the database and monitoring of time spent on tasks. /liliProvide Database Programming input into protocol data collection assessments. /liliCreate the annotated CRF (aCRF) using company standards or Sponsor’s naming conventions in accordance with relevant company procedures. /liliAccountable for building 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 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 such as ICH, GCP, etc. to day‑to‑day activities and generate all required documentation for study files. /liliLead the DBP team, coordinate other DBP staff, provide direction regarding work assignment, scheduling and prioritizing, and 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 escalates issues to resolution at the appropriate level. /liliProve ability to analyse data capture problems/opportunities and deliver 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). /liliRepresent Database Programming in internal or external meetings (e.g., EDC demos). /liliConduct other activities as required. /li /ulh3Qualifications /h3ulliDegree (preferably in Computer Science) or at least 6 years of experience in database programming or a similar role within a pharmaceutical environment or equivalent. /liliKnowledge of Alira Health systems. /liliVery good knowledge of Data Management processes and pharmaceutical industry guidelines such as ICH, GCP, etc. /liliExpert knowledge in one or more clinical data management systems and recognized for expertise (e.g., Medidata Rave, Merative Zelta). /liliKnowledge of SAS programming. /li /ulh3Desired Qualifications Experience /h3ulliExpert on Merative Zelta build and/or Medidata Rave build; certification of study builder is an added value. /li /ulh3Technical Competences Soft Skills /h3ulliEnglish language proficiency. /liliGood MS Office Suite skills. /liliProfessional trustworthiness. /liliAbility to effectively prioritize. /liliQuality focus. /liliPersonable attitude. /liliWillingness to learn. /liliTeam player. /liliEffective stress management techniques. /liliLearning agility. /liliConflict management. /liliProblem‑solving skills. /liliEffective verbal communication. /liliCommercial and technical writing. /liliNetworking skills. /liliAnalytical thinking. /liliResilience. /liliAbility to influence and motivate. /liliRapid conflict resolution. /liliInnovation. /liliConstructive feedback. /liliExcellent presentation skills. /liliCommercial awareness. /liliTalent development. /li /ulh3Languages /h3ulliEnglish /li /ulh3Contract Type /h3ulliHourly /li /ul /p #J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7bhq5h