Freelance Principal Database Programmer
SKILLS
FULL DESCRIPTION
Freelance Principal Database Programmer
[Employer hidden — view at passion-project.co.uk] is seeking a Freelance Principal Database Programmer for a 0.5 FTE contract role within the CDS Ophthalmology team. The role involves setting up study databases, programming edit checks, performing validation, managing budgets, and mentoring junior staff. Requires a Bachelor's degree in life science or computer science, 8+ years of database programming experience in pharma/CRO, and familiarity with CDMS, SAS, 21 CFR Part 11, and GAMP. This is a fully remote position with locations in the UK, Poland, or USA.
Key Responsibilities
- Provide training and mentoring to (Senior) Database Programmers related to CDMS systems and processes
- Plan client deliverables and manage project budgets
- Act as programming lead for a study/program
- Setup of study databases and ePRO/IRT based on provided specifications
- May write or review the Database Validation Plan
- Perform database validation/UAT in collaboration with CDM
- May review Data Validation Plan 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
- May perform or support CDM with validation of Data transfer programming
- Create and manage users incl. access rights
- 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 [Employer hidden]
- Provide input into proposals which include Data Management and may attend Bid Defense meetings
Qualifications
- 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
We provide a competitive compensation package, comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients.
About [Employer hidden — sign up to reveal]
Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 600 professionals, [Employer hidden — sign up to reveal] delivers tailored clinical research services in more than 50 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction.
Department: CDS Ophthalmology
Locations: Multiple locations
Remote status: Fully Remote
Employment type: Contract
Work Arrangement: Remote
REQ ID: reqID483988