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:

Bachelors 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

For candidates based in Italy - we welcome applications from candidates belonging to protected categories under art. 1 L. 68/99.

For candidates based in Sapin - TFS is committed to equal opportunities. All our vacancies are open to people with disabilities in accordance with the General Law on the Rights of Persons with Disabilities (Royal Legislative Decree 1/2013).

What We Offer

We provide a competitive compensation package comprehensive benefits and the opportunity for personal and professional growth in a rewarding environment. Youll 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.