Assignment Description

Our client is currently seeking a Study Design Analyst.

Our client is building a new health-tech business, delivering market-leading digital health solutions that are science-based, evidence-led, and human experience-driven. Thoughtful risks and quick decisions drive innovation across the life sciences sector. Be part of a diverse team that pushes the boundaries of science by digitally empowering a deeper understanding of the patients they are helping. Launch pioneering digital solutions that improve the patient experience and deliver better health outcomes. Together, they have the opportunity to combine deep scientific expertise with digital and artificial intelligence to serve the wider healthcare community and create new standards across the sector.

About the Role

Our client is a growing digital product development and engineering organization passionate about delivering innovative solutions to patients and healthcare professionals in clinical studies. In this role on their Customer Delivery team, you’ll lead the design and deployment of their platform for clinical trials. You’ll translate complex clinical protocols into system configurations, manage the design process, and ensure the successful implementation of their Unified Trial Platform. Your expertise will shape the future of clinical studies, making healthcare more efficient and accessible.

Accountabilities

Study Implementation:

• Lead the design and configuration of the Unified Trial Platform, ensuring clinical protocols are effectively translated into system configurations.
• Act as a consultant to the sponsor team, serving as a domain expert on digital solutions and providing insights into system capabilities, configuration options, and practical applications in clinical trials.
• Manage the overall study configuration and design process, implementing best practices and leveraging reusable assets such as eCOA libraries and translations.
• Partner closely with internal and external stakeholders on translations, assessment licensing, integration, validation, and quality control.

Pre- and Post-Implementation:

• Support the team in assessing upcoming clinical trials, consulting on solutions and delivery methods that best meet the study’s needs.
• Conduct risk assessments and impact analysis of new software releases, upgrades, and changes.
• Provide ongoing support and guidance to clinical trial and implementation teams during the deployment and post-implementation phases, including addressing issues and implementing improvements as needed.

Desired Attributes:

• Enjoy working in a team, collaborating with peers to find solutions to challenges, and improving processes after each project.
• Are adaptable and able to pivot strategies in response to changing business needs. Our products get better with every release, and clinical protocols evolve.
• Focus on quality and ask customers questions to clarify requirements.
• Are comfortable saying “no” to customers while providing consultative solutions to design the best studies in our client’s software.

Minimum Qualifications:

• 4-7 years of experience in building and configuring digital solutions for clinical trials, including 3 years specifically with eCOA systems.
• Proven senior stakeholder management skills, including negotiation, collaboration, and interpersonal leadership abilities, coupled with the ability to work collaboratively in a cross-functional setting with both internal and external partners.
• Demonstrable experience in gathering and translating business requirements into technical specifications and configurations for digital solutions used in clinical trials.
• Strong understanding of clinical trial processes and regulations related to study design.
• Bachelor’s degree in relevant information technology, life sciences, or a related field preferred.
• Experience with connected devices (e.g., PEF, oxygen monitors) and integrating with other clinical systems, such as IVRS, EDC, data lakes, etc.
• Excellent analytical, problem-solving, and communication skills, with the ability to interact effectively with team members and customers at all levels.
• Strong judgment and insights with sensitivity to the environment.

Desirable Qualifications:

• Master’s degree in a relevant discipline.
• Experience in healthcare and life sciences, preferably with clinical trials.
• Experience working in a global organization with complex/geographically dispersed contexts.
• Experience working in a regulated environment, ideally delivering GxP and SaMD solutions.

Location: Sweden, Mölndal (three days per week on-site)

Language: Fluent English