Rubrik:

Produkter:

GxP,SaMD,Life Sciences,eCOA

Roller:

Projektledare

Distrikt:

Gbg

Beskrivning:

In this role on our Customer Delivery team, you’ll lead the design and deployment of our platform for clinical trials. You’ll translate complex clinical protocols into system configuration, manage the design process, and ensure the successful implementation of our 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 Unified Trial Platform, ensuring clinical protocols are effectively translated into system configuration. • Be consultative with the sponsor team, serving as a domain expert on our digital solution and providing insights into the system capabilities, configuration options and practical application of its features in a clinical trial. • Manage the overall study configuration and design process, implementing design best practices and leveraging reusable assets such as eCOA libraries and translations. • Be a close partner with internal and external partners with respect to translations, assessment licensing, integration, validation and quality control. Pre- and Post-Implementation • Support the team on assessing upcoming clinical trials, consulting on solutions and delivery methods that best meet the study’s needs. • Conduct risk assessment 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. About you… • Love working on a team, collaborating with your peers to find solutions to challenges, and making the process better after each project. • Are adaptable, able to pivot strategies in response to changing business needs. Our products get better with every release. Clinical protocols also change. • Have a focus on quality and ask customers questions to clarify requirements. • Be comfortable saying “no” to customers and provide consultative solutions to design the best studies in software. Minimum Qualifications: • 4-7 years of experience in building and configuring digital solutions for clinical trials; 3 years of experience 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 of 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 with respect to study design • Bachelor’s degree in relevant information technology, life science or 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 • Excellent discernment and insights with sensitivity to environment Desirable Qualifications: • Master degree in relevant discipline • Experience from Healthcare and Life Sciences, preferably with clinical trials • Experience of working in a global organization with complex/geographical context • Experience of working in a regulated environment, ideally of delivering GxP and SaMD solutions Location: Sweden, (three days per week on site)

Anmälan till uppdrag 5324

Personuppgifter -*obligatorisk uppgift

Hemuppgifter

CV o Personligt brev (Word,PDF,Text) / Foto (JPEG)

Företagsuppgifter - Om du är anställd eller företagare

Tipsuppgifter - Var fick du tips om KonsultPoolen