Principal Database Programmer

Alira Health-posted 2 months ago
Mid Level
Milan, TN
501-1,000 employees
Professional, Scientific, and Technical Services
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ROLE The Principal Database Programmer role involves the following characteristics: Lead and drive the DBP team, acting as mentor and coach Contribute to develop the clinical database to collect the clinical data provided on paper or electronic CRFs Program the computerized checks or SAS checks to ensure clean, accurate and complete clinical data can be delivered to customers Act 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 budget Make recommendation for process improvement and/or new standards development Effective input into strategic planning across the department Bridge scientific or medical knowledge into database programming processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets

  • Accountable for driving achievement of project milestones from study start up through to delivery of database and monitoring of time spent on tasks
  • Provide Database Programming input into the protocol data collection assessments
  • Create the annotated CRF (aCRF) using company standards or Sponsor's naming conventions in accordance to relevant company procedures
  • Accountable for building of 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 his/her own 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 like ICH, GCP etc to day-to-day activities generating all the required documentation for study files
  • Lead the DBP team, coordinate other DBP staff providing direction regarding work assignment, scheduling and prioritizing; 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 escalate issues to resolution at the appropriate level
  • Proven ability to analyse data capture problems/opportunities and a track record of developing and delivering 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)
  • Make recommendations for process improvements and development of new standards
  • Effectively represents Database Programming in internal or external meetings (e.g. EDC demos)
  • Conduct other activities as required
  • Expert on Merative Zelta build and/or Medidata Rave build, certification of study builder will be an added value
  • Degree (preferably in Computer Science) or at least 6 years of experience in database programming field or similar in a pharmaceutical environment or equivalent
  • Knowledge of Alira Health systems, Very Good
  • Knowledge of Data Management processes, Very Good
  • Knowledge of pharmaceutical industry guidelines like ICH, GCP etc, Very Good
  • Expert in one or more clinical data management systems and recognized for expertise
  • Knowledge of SAS programming, Very Good
  • English, Good
  • MS Office Suite, Good
  • Professional
  • Trustworthy
  • Ability to effectively prioritize
  • Quality focused
  • Personable Attitude
  • Willingness to learn
  • Team Player
  • Effective Stress Management Techniques
  • Learning Agility
  • Ability to Manage Conflict
  • Problem Solving Skills
  • Effective Verbal Communication Skills
  • Commercial and Technical Writing Skills
  • Networking Skills
  • Analytical thinking
  • Resilient
  • Ability to Influence and motivate
  • Ability to manage difficult conversations
  • Innovative
  • Ability to Provide Constructive Feedback
  • Excellent Presentation Skills
  • Commercial awareness
  • Ability to recognize and develop talent
  • Expert on Merative Zelta build and/or Medidata Rave build, certification of study builder will be an added value
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