Clinical Studies Engineer

You are at the front lines of the digital health revolution. You’ll join a top talent, fun, diverse, tight-knit team of experienced professionals who have worked in healthcare, technology, and consumer across multiple functions. We think big and bold, and relentlessly execute.

You are central to the success of our clinical studies. You operate hands in hands with our clinical trial manager to oversee the design, planning, documentation, and execution of clinical studies to assess the safety and effectiveness of our products. You master the science of clinical study design and statistics. You are the cornerstone between product and R&D on one end, and clinical and regulatory on the other end. You design innovative clinical study strategies to validate the impact of our digital health interventions on prenatal care, birth outcomes, and healthcare economics. You interface with a variety of internal and external stakeholders, and ensure that studies are designed and run with a high level of scientific integrity.  You’re experienced in traditional clinical study designs such as equivalence studies and RCT, and eager to translate them into non-traditional studies leveraging real-world evidence.

Your responsibilities include:

• Design and manage clinical studies to validate the safety and efficacy and impact of Bloomlife products and services, or to support the development of new features
• Develop study-related documents, including: Study Protocols, Data Management Plan, Statistical Analysis Plan, Data Collection Procedure, and work with Clinical Trials Manager to coordinate distribution to / communication with investigational sites, review committees and national authorities
• Work with Clinical Data Engineers to monitor the integrity and quality of the data (sensor and clinical) collected during the studies, identify possible data issues and escalate to the technical and engineering team as quickly as possible
• Manage clinical research & development projects: define project plan, organize project execution to ensure that all deliverables and milestones are met on time, monitor progress and report to executive management and to funding agencies, coordinate technical activities associated with study start-up, logistics and execution
• Manage distribution, collection, and tracking of regulatory documentation to assure audit readiness
• Visit clinical sites in Europe and US on a regular basis, to set-up and monitor studies, assist with the technical aspects, and to ensure compliance with SOPs and local regulations, and ICH and GCP guidelines
• Report progress to clinical and algorithm team and to executive management
• Develop and maintain study procedures, forms and templates in compliance with applicable regulation
• Provide guidance on industry best practices around clinical study design and execution, in alignment with applicable regulation and standards

Requirements

You’re a passionate clinical or biomedical engineer. You live to create scientifically grounded evidence that supports new medical devices and show how they impact prenatal care and birth outcomes. You’re curious. You’re critical. You embrace new challenges and challenge the status quo. You’re proud of well designed and well run studies that yield results that advance scientific and clinical knowledge.  

To succeed in this role, you must have:

• Background in Biomedical Engineering, Clinical Engineering, Biomedical Science or equivalent through experience
• 3+ year experience running clinical trials for medical devices 
• Experience designing, setting up, executing and managing multi-site clinical studies 
• Good communication and interpersonal skills

Additionally, it will help to have:

• Experience interfacing with ethics committee, IRB and regulatory bodies
• Working knowledge of Good Clinical Practice for Medical Devices (ISO 14155)
• Familiar with digital health products and connected devices
• Working knowledge of data visualization and scientific software is a plus
• Experience designing and running clinical trials for CE marking or FDA certification is a plus
• Experience designing and running a RCT is a plus

Benefits

Bloomlife is an award-winning start-up recognized for our vision to rethink prenatal care and impact the lives of families globally including winning Richard Branson’s Extreme Tech Challenge, J&J Quickfire Challenge Winner, MedTech Innovator Award, Ideas from Europe Finalist, CLIO Award Finalist, and speaking at the White House Precision Public Health Summit. Bloomlife also recently got FDA clearance for its prenatal wearable for monitoring maternal and fetal heart heart rate, setting new grounds to move prenatal check-ups from expensive hospital environments to the patient’s home. 

You will join a dynamic and international team who’s passionate about using technologies for a better living. You are an early member of a growing start-up with recent successes and get to experience first hand the excitement of start-up life. Your work will be highly visible to company founders, directly shape our products and impact people’s lives, and open opportunities for personal and career development. 

We offer a flexible work environment, remote work culture and a compensation package combining salary and stock options. You are based in our Liege or Eindhoven office.