Life Science Project Manager (Clinical Trials & Healthcare Projects for SaMD)
hace 16 días
A Coruña
About us Legit.Health deploys computer vision and artificial intelligence technology to enable lifesaving diagnosis and therapies for visible diseases. Our goal is to enable universal access to high-quality diagnosis and follow-up of pathologies and to offer affordable health assistance to everyone everywhere. Things you should know before following and signing up for the position: We are a startup, it is important that you are knowledgeable about how startups operate and know that at this stage there are more unknowns than certainties. There are many things to discover and define yet, so you will be part of that definition, therefore you will have many functions helping the management. At Legit.Health we have a friendly open collaborative culture and a united team vision. We love entrepreneurial/risk taking/high ambition mindsets. Our work is rewarding and we help each other win by creating a supportive and collaborative environment for one another. Take a look at our opening below and send us your application - we look forward to hearing from you! Job description We are on the lookout for a passionate Life Science Project Manager with a focus on clinical trials and healthcare innovation and a specialization in software medical devices, eager to drive innovation in the evolving landscape of digital health. This pivotal role involves leading the development and implementation of transformative projects in healthcare technology from conception to delivery. The ideal candidate will bridge the gap between commercial, clinical and technical teams, translating customer needs into actionable specifications, and ensuring our solutions not only meet the high standards required by our health sector partners and their patients but also stay within budget and time constraints while adhering to regulatory requirements. A key part of your role will be working with partners (hospitals, CROs, and research institutions), ensuring proper study design, execution, and integration of our technology into customer workflows. Note on collaboration and roles: You’ll work alongside a Deal Owner, who leads the commercial relationship, and a Customer Success Manager, responsible for post-sale client engagement and support. This setup allows you to focus on implementation, delivery, execution, and providing clinical, technical and regulatory advisory to the customer—without managing the client relationship end-to-end. Your responsibilities will center on translating clinical and business needs into clear project plans and specifications, ensuring successful execution across all phases. While deep technical expertise is not required, a solid foundational understanding of data and technical concepts—such as database structures, data transfer specifications, integrations, and system requirements—is essential to effectively coordinate with technical teams and support seamless projects from definition to the delivery. You will also provide clinical, technical, and regulatory guidance to customers—without being responsible for managing the full client relationship lifecycle. What you need to achieve • Project planning and execution: Develop and track detailed project plans, manage changes to project scope, schedule, ensuring successful project execution within time, and scope constraints. - Daily customer interaction: Collaborate with customers, investigators, CROs, and Sponsors to ensure project success - Team liaison: Act as the crucial link between the commercial team and the product team, facilitating effective communication and ensuring customer needs translate into clear and achievable technical specifications. - Technical and regulatory customer advisory: Provide expert support to help customers generate and understand the best use case for our software medical device, including explaining technical aspects related to product, as well as regulatory feasibility and data protection issues. - Functional and Technical requirements analysis: Thoroughly assess project needs and specifications to ensure alignment with product objectives and customer expectations. - Holistic view of healthcare processes: Offer a comprehensive perspective of healthcare processes to help and support the team in developing effective solutions. - Development specifications and Product documentation Definition: Clearly establish development requirements and ensure the creation of accurate and complete product documentation. - Product strategy participation: Actively contribute to the definition and adjustment of product strategy, ensuring its relevance and success in the market. Must have • Strong knowledge of Good Clinical Practice (GCP) and clinical research regulations - Proven experience in project management, especially in the development of software medical devices within the health, biotechnology, or digital health sectors (hospitals, CROs, Sponsors, research institutions). - Specific knowledge of AI technologies applied to health and previous experience in dermatology or related fields. - Understanding of medical device regulation, including familiarity with software medical device regulatory frameworks and compliance. - Basic knowledge of data protection laws, such as GDPR and HIPAA compliance, to ensure our products meet the necessary data privacy and security standards. - Deep understanding of the health industry, including B2B dynamics and specific regulations for software medical devices. - Exceptional communication skills, capable of effectively interacting with technical teams, healthcare professionals, and business stakeholders, explaining complex concepts in a clear and accessible manner. - Effective leadership, with experience leading multifunctional teams in dynamic and demanding environments. - Degree in Business Administration, Health Management, Biotechnology or a related field. Project management certification (e.g., PMP, PRINCE2) is highly valued. Nice to have • Experience with data transfer specifications, database structures, and system integrations in the context of clinical or research studies. - Familiarity with clinical data management systems (CDMS), electronic data capture (EDC) platforms, and clinical trial software (e.g., Medidata, REDCap, OpenClinica). - Knowledge of healthcare processes and management systems, such as HIS/EHR/EMR, RIS, LIS, PACS, or ERP, as well as standards like FHIR and HL7v2. - Foundational programming knowledge in programming languages such as PHP, JavaScript, or Python. Important • Able to work autonomously, with discipline and with high motivation and energy - Proactive, willing to learn, have an impact and grow in the company - Team player capable of adapting to changes in a fast-paced environment What do we offer ️ • Full-remote position. We are a team of committed professionals, so you choose where you work from and also means that all processes need to be thought of as if we had no office and everyone is working remotely. No one will feel like an outsider, since all conversation will need to happen on slack or hangouts. - Working in a fast growing Start-up environment within an international context - Flexible compensation: daycare and restaurant - Flexible vacation policy: 23 working days per year + 2 additional days granted by the company (your birthday and December 7th) + 2 days for company closure per labor agreement (December 24th and 31st) - Flexible working hours - Full time contract - Starting day: as soon as possible. - Competitive salary according to your experience Languages • High Spanish and English proficiency (writing and speaking). - Additional languages are a plus In compliance with the provisions of the data protection regulations, we inform you that the personal data you have provided with your resume will be processed in a mixed manner (automated or not) by AI Labs Group, S.L., with NIF B95988127 and address in Gran Vía, 1, BAT Tower, Bilbao (Bizkaia), 48001 (hereinafter, Legit.Health). The purpose of this data processing is the management of Legit.Health's personnel selection processes and is based on your prior consent. Your data will be kept for one year, after which we will proceed to cancel it. You are also informed that no automated decisions will be made. Your data will not be transferred to third parties. At any time you can exercise your rights of access, rectification, deletion, portability, limitation, or opposition, by writing to the email . We also inform you that you can go to the Control Authority to assert your data protection rights. *Please note that this is not an email to submit job applications. We are only processing the data you have provided for specific personnel selection processes. If you wish to apply for a position, please follow the instructions on our official job postings. Sincerely, Legit.Health team.
