Senior Database Programmer

Alira HealthBoston, MA
6d

About The Position

ROLE The Senior Database Programmer role includes: Contribute to develop the clinical database to collect the clinical data provided on paper or electronic CRFs on Medrio 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 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 Bridge scientific or medical knowledge into database programming processes to ensure sound data collection tools, validations and integration to fit for purpose clinical datasets Alira Health is a global advisory firm providing consulting and research and clinical development services whose mission is to humanize healthcare and life sciences, in partnership with patients, through innovative technologies and expert guidance. From development to medical care, we complement the expertise of our Pharma, Biotech, and MedTech clients with a full spectrum of services across their entire solutions lifecycle. With offices around the world, Alira Health provides a vibrant and creative environment with benefits that include professional development, global travel, flexible work programs and more. We welcome your passion and drive, talent and entrepreneurial spirit, sense of service and teamwork. We are an integrated team of over 800 scientists, strategists, economists, clinicians, and biostatisticians representing over 30 nationalities. This broad global perspective and cultural richness has a direct impact on providing innovative solutions for our clients that lead to higher standards of care and an improved patient experience. Learn more Introduce yourself to our Recruiters! Apply to one of our open jobs or send us your spontaneous application.

Requirements

  • Degree (preferably in Computer Science) or at least 3 years of experience in database programming field or similar in a pharmaceutical environment or equivalent
  • Knowledge of pharmaceutical industry guidelines like ICH, GCP etc, Good
  • Expert in one or more clinical data management systems and recognized for expertise
  • Knowledge of SAS programming, Good
  • English, Good
  • MS Office Suite, Good
  • Professional
  • Trustworthy
  • Ability to effectively prioritize assigned work
  • Quality focused
  • Personable
  • Attitude
  • Willingness to learn
  • Team Player
  • Learning Agility
  • Problem Solving Skills
  • Effective Verbal and Written Communication Skills
  • Networking Skills

Nice To Haves

  • Recent experience in CRF building on Medrio
  • Knowledge of Alira Health systems, Very Good
  • Knowledge of Data Management processes, Good

Responsibilities

  • Accountable for achieving project milestones from study start up through to delivery of database and monitoring of time spent on tasks
  • Create the annotated CRF (aCRF) using company standards or Sponsor’s naming conventions in accordance to relevant company procedures
  • Build 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 prioritize 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 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
  • Educate/train on use of study specific data collection tool(s)
  • Proven ability to analyze data capture problems/opportunities and a track record of developing and delivering high quality solutions
  • Conduct other activities as required
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