Senior Staff Developer modernizing DevEx, cloud platforms, and AI - assisted delivery at Benevity. Building secure engineering systems that help companies enable social action.
TO
Freelance Principal Database Programmer
Posted 5 months ago
About the role
- Principal Database Programmer at TFS HealthScience managing clinical data management tasks. Joining a dedicated team in a fully remote role to enhance healthcare research.
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
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
Benefits
- Competitive compensation package
- Comprehensive benefits
- Opportunity for personal and professional growth
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