Principal Database Programmer

TFS HealthScience•Auburn, ME

4d•Remote

About The Position

The Principal Database Programmer is part of the Global Biometrics Department within Clinical Development and will work operationally on preparing, conducting and completing Clinical Data Management tasks on assigned Study Teams, according to company policies, SOPs and regulatory requirements.

Requirements

Bachelor’s Degree, preferably in life science, computer science or equivalent
Minimum of 8 years relevant database programming experience in pharmaceutical or CRO industry, including 5 years as Senior Database Programmer
Familiarity with different CDMS systems and industry standards applicable for programming in GxP environment (e.g. 21 CFR part 11, GAMP)
Ability to handle multiple tasks to meet deadlines
Proven leadership skills
Excellent verbal and communication skills
Ability to deal effectively with sponsors and internal customers
Ability and willingness to travel on occasion

Responsibilities

Provide training and mentoring to (Senior) Database Programmers related to CDMS systems and processes to be performed by Database Programmers
Plan client deliverables and manage project budgets
Act as programming lead for a study/ program
Setup of study databases and ePRO/ IRT (if applicable) based on provided specifications (e.g. dummy CRF pages, study design specification, URS)
May write or review the Database Validation Plan
Perform database validation/ UAT in collaboration with CDM
May review Data Validation Plan (DVP) with regards to feasibility of checks in CDMS
Program edit checks within CDM systems and/ or SAS according to data validation plan
May write or support CDM with creation of edit check test plan
May perform or support CDM with import and export of data
May write or support CDM with creation of data transfer specifications including liaising with vendors to facilitate connections between CDMS and other systems
May perform or support CDM with validation of Data transfer programming
Create and manage users incl. access rights (if applicable)
Provide helpdesk for users in EDC studies
Perform the execution of the database lock in collaboration with CDM
File/ archive essential documents
Responsible to escalate any issues on projects or the need for potential SOP deviations
Perform system validation, create test scripts for system validation as well as perform UAT
Actively contribute to the organization and development of processes to enhance the work at TFS (e.g. writing/ review of SOPs including related documents and perform training)
Provide input into proposals which include Data Management and may attend Bid Defense meetings