About
Do you excel at ensuring software quality in highly regulated environments where precision truly matters? Are you driven by testing and validating systems that support impactful clinical trials that may help patients across the world? Can you see yourself leading validation efforts while collaborating across teams to deliver compliant, high-quality software solutions?
Then you may be a perfect match for Studies&Me! We´re looking for a software validation tester, with a proactive mindset, passion for quality and compliance and good communication and collaboration skills. The position is a 1-year maternity cover, with the possibility of an extension or a permanent position.
Who are we?
Studies&Me is a young health tech company that focuses on building electronic outcome assessments (eCOA) elements for clinical trials. We take pride in designing and building our own software tools with the purpose of revolutionizing the way clinical studies are conducted, to make life easier for patients and doctors alike. Studies&Me is a part of the Sanos organization, a full-circle global multi-niche contract research organization (CRO), which will also give you the opportunity to interact with and learn about all aspects of clinical trials. Become a part of our highly motivated and close-knit team, fueled by a passion for science, innovation, and making a tangible difference in people's lives.
Working with us in Studies&Me, your impact will matter.
Your key roles and responsibilities
As a Software validation tester with Studies&Me, you will play a pivotal role in ensuring high quality software tools used for data collection in clinical trials. Your responsibilities will encompass a wide range of activities, with the key focus being testing and validating new software tools before they are released to our clients. Your tasks and responsibilities will include:
- Informal software testing: Driving, planning, and executing informal test activities in a small agile environment. Ensure the function and quality of newly built software. Ensure that tasks are delegated and progress according to timelines by driving coordination of execution.
- Validation activities: Defining URS/FRS, drafting validation documentation such as validation plans, summary reports, release guidelines, etc. Plan and write validation test scripts and ensure they are in line with URS/FRS. Execute and document validation tests.
- Study specific validation: Set up new clinical trials according to requirements and plan validation activities prior to setting a new trial live.
- Quality assurance and regulatory compliance: Ensure our product and validation is compliant with ICH-GCP and other regulatory requirements and guidelines.
- Software improvements: In collaboration with the team, propose and discuss new features improving our software solutions.
- Ad hoc: Data reviews, risk assessments, incident resolution, customer communication, process optimizations, updating SOPs and other internal documentation.
In this role, you will have the opportunity to make a meaningful impact on the success of clinical trials, driving innovation and excellence in every aspect of your work.
Desired skills and experience
Professional profile
We are seeking you, who have professional experience in a role within or related to software validation, ideally within health tec. Clinical trial experience is not mandatory, but a big plus. We do not require a specific educational level, but a master’s degree in health sciences / health tech / data science is considered a plus. You should have experience using tools such as Jira and Github, and working according to GAMP-5 as well as ICH-GCP and other regulatory guidelines on computerized systems.
You have a pragmatic mindset, an eye for detail, and have a genuine interest in software validation, as this is where your key responsibilities will be. You are great at communicating, collaborating, and can plan and prioritize your time to meet deadlines. You have an eye for detail. As we are an international team, you must be fluent in English.
Personal profile
As a person, you have a can-do attitude and are eager to learn new things. You work independently with persistence and are a structured, organized, and a proactive problem-solver. You are a team player with good communication skills and thrive in fast-paced environments. You have a natural keen interest in software validation and quality assurance and possess the ability to handle high levels of complexity. You have high levels of empathy, but also the necessary stamina to execute and influence as the situation requires. You seek responsibility and take ownership of projects independently. With an open-minded and flexible attitude, you adapt well to changes. You follow through on commitments and keep deadlines. You embrace the importance of a good work environment where colleagues thrive and there is room for individualism.
Are we a perfect cultural fit?
Our commitment to you is encapsulated in our promise to every one of our employees saying ‘Trust in you - in your development and impact´.
This pledge extends uniformly across all entities within the Sanos Group organization, including Studies&Me, ensuring that you feel its effects from the very offset of your interaction.
If you are curious about whether you would thrive within the Sanos Group culture and the Sanos Way of Leading, reflect on whether you see yourself working within our principles:
- Take on - Responsibility is given, and we inspire you to take it.
- Try out - Explore diverse tasks and grow professionally.
- Team up - We don’t just work together; we thrive together.
Apply and make a real impact
Discover a professional journey like no other. We are small enough to empower every individual yet powerful enough to drive transformative changes in the future of healthcare. We are committed to pushing the boundaries of the world of clinical trials, ultimately accelerating the availability of new treatments for patients in need.
Be a part of our journey and help us pave the way for a healthier future.
To apply for this position, please submit your CV and a motivated application via the "Apply" link. The position is available 01 September 2026, and the workplace is located at our office in Copenhagen K, Sølvgade 10. Applications are reviewed on an ongoing basis, and the position will be closed once we find the right candidate.
For any questions or further information about the role, feel free to contact Mathias Namini, Associate Director, at mna@sanos.com. Please note that assessments may be part of the recruitment process.
Due to the nature of the role and the need for close collaboration in the team, being physically present at our office is essential for success. However, Studies&Me offers a flexible work-life balance, including the possibility to work from home, as agreed with line management.
We encourage all qualified candidates to apply for the position – regardless of ethnic background, gender, sexual orientation, disability, religion, or age.
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