Senior Database Programmer

Alira Health•Boston, MA

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

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
TECHNICAL COMPETENCES & SOFT SKILLS
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
Languages
English

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