Principal Database Programmer

Principal Database Programmer - 0.5 FTE FREELANCE / UK/ POLAND/ USA TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service-capabilities, resourcing and Functional Service (FSP) solutions. Join Our Team as a Principal Database Programmer About this role As part of our CDS Ophthalmology team you will working alongside passionate and innovative professionals to ensure our customers achieve their goals. 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. Key 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 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 A Bit More About Us 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, TFS 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. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.