Principal Database Programmer

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ResponsibilitiesAccountable for driving achievement of project milestones from study start?up through to delivery of the database and monitoring of time spent on tasks.Provide Database Programming input into protocol data collection assessments.Create the annotated CRF (aCRF) using company standards or Sponsor's naming conventions in accordance with relevant company procedures.Accountable for building the clinical database, creating variables, codelists, forms and visits in accordance with the aCRF.Develop the computerized checks in accordance with the Data Validation Plan.Develop SAS checks in accordance with the Data Validation Plan.Implement mid?study changes to the production eCRF when requested by the Lead DM.Communicate the database setup status and the achievement of milestones to the Lead DM.Create and validate import programs of electronic data received from external vendors.Import electronic data received from external vendors during the course of the clinical study.Program and validate data listings (e.G., Manual checks, Medical Review listings, Coding report, etc.).
Program and validate tracking or metric reports.Plan and prioritise work and take appropriate actions (e.G., escalation).
Contribute in formal training for new database programming staff.Apply 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.Lead the DBP team, coordinate other DBP staff, provide direction regarding work assignment, scheduling and prioritizing,



and monitor progress of activities.Maintain continuous and appropriate communication with Lead DM and/or study Project Manager and share critical and general issues.Develop and maintain a network of contacts within the study team.Make recommendations for database setup process improvements and development of new standards.Input into and monitor progress against study project plan and escalates issues to resolution at the appropriate level.Prove ability to analyse data capture problems/opportunities and deliver high?quality solutions.Demonstrate broad and integrated knowledge of all aspects of Database Programming, providing consultancy to other groups outside DBP.Educate/train on use of study?specific data collection tool(s).
Represent Database Programming in internal or external meetings (e.G., EDC demos).
Conduct other activities as required.QualificationsDegree (preferably in Computer Science) or at least 6 years of experience in database programming or a similar role within a pharmaceutical environment or equivalent.Knowledge of Alira Health systems.Very good knowledge of Data Management processes and pharmaceutical industry guidelines such as ICH, GCP, etc.Expert knowledge in one or more clinical data management systems and recognized for expertise (e.G., Medidata Rave, Merative Zelta).
Knowledge of SAS programming.Desired Qualifications & ExperienceExpert on Merative Zelta build and/or Medidata Rave build; certification of study builder is an added value.Technical Competences & Soft SkillsEnglish language proficiency.Good MS Office Suite skills.Professional trustworthiness.Ability to effectively prioritize.Quality focus.Personable attitude.Willingness to learn.Team player.Effective stress management techniques.Learning agility.Conflict management.Problem?solving skills.Effective verbal communication.Commercial and technical writing.Networking skills.Analytical thinking.Resilience.Ability to influence and motivate.Rapid conflict resolution.Innovation.Constructive feedback.Excellent presentation skills.Commercial awareness.Talent development.LanguagesEnglishContract TypeHourly#J-*****-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/79ekbz