Clinical Project Manager
Science- Business Dev – Operations /
Each and every night, around the world, hundreds of millions of people are trying to sleep but can’t. We’re in the middle of a global sleep crisis with serious ramifications for society. At Dreem, a team of 50 experts is on a mission to solve sleep disorders. By merging advanced technologies and sleep medicine, we are developing new ways to analyse and improve sleep - building the sleep medicine of tomorrow.
In the 7 years since Dreem’s creation, we’ve collected 2M nights of sleep data and helped tens of thousands of people improve their sleep. We also accumulated 45 patents, completed 3 full hardware iterations and 100s of software iterations. We raised $60M from investors including Laurent Alexandre, Xavier Niel, MAIF, BPI and Johnson & Johnson - the world’s healthcare leader. Along the way we also created a research network of 250 leading laboratories and hospitals, and a scientific board of 4 of the most renowned neuroscientists and sleep experts in the world.
Dreem is a fast-paced and dynamic work environment. The team’s fields of expertise encompass sleep research, neuroscience, behavioral therapies, mechanical engineering, machine learning, electronic design, embedded systems, testing, ergonomics, development of proprietary applications and software, product design, marketing and much more. Joining the team is challenging but hugely rewarding - it means pushing the boundaries of science and being able to bring real positive change to people around the world.
Dreem has been building a digital sleep clinic, providing comprehensive patient care to answer the growing needs of people suffering from sleep disorders - from screening, diagnosis, to the treatment of insomnia and apnea. By facilitating access to remote care, while improving diagnosis and treatment methods, the Dreem clinic is a unique alliance of advanced technology and sleep medicine, providing US payers with lower costs, improved clinical performance, and increased patient satisfaction.
Dreem digital sleep clinic services are also used in the context of clinical trials by 250 research labs - including the Harvard Medical School, Brown University, Stanford University, Bard College, and 10 pharmaceutical companies.
In this context, we partner with pharmaceutical companies to identify new biomarkers and diagnosis approaches that we use for streamlining sleep diagnosis and treatment monitoring. We are looking for a brilliant teammate who wants to help to include innovative ways to measure sleep in clinical trials.
As part of the clinical team, you will have a pivotal role by being responsible for the planning, organization and execution of 4-6 clinical trials in which Dreem is included as a vendor.
- Ensure that the studies (today mostly phases I & II but phases III & IV will arrive soon), in which Dreem is involved as a vendor, are delivered on time, within budget, and agreed scope, maintaining the appropriate, industry, sponsor or CRO quality standard.
- Be the the primary project contact with the client (pharmaceutical companies, CROs, sites) on every topic related to the study
- Identify issues that might endanger study timelines/deliverables and offer proactive, creative action/risk assessment and contingency plans to the team/sponsor;
- Managing operational implementation of study start-up (prepare or review project management plan, data management plan, communication plan, patient instruction manuals, site instruction manuals, data transfer agreements; handle logistic management, study set-up management , etc) and close-out activities.
- Carefully training the sites for Dreem’s usage and ensuring effective communication with them throughout the study.
- Surveillance of data compliance and quality & reviewing of data files.
- Ensuring that team members (care team, engineers) are properly trained with regard to the protocol, functional activities, and all study related procedures,
- Ensuring the studies are always managed in accordance with GCP and all SOPs and regulations.
- Monthly financial reporting & assessing the need for change orders & implement them.
- Participating in external/internal audits.
- Suggest product improvements, based on client feedback.
- Involvement in Big Consortium (IMI, H2020, etc) as project manager.
REQUIRED EXPERIENCE & SKILLS
- Minimum: Master Degree or engineering school in medical sciences; PhD is a strong plus
- At least 2 years of experience in clinical trials;
- Strong appetence for the sleep research fields;
- Based in France or east US;
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements - i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines;
- In depth therapeutic and protocol knowledge;
- Strong communication (fluent or native English speaker) and presentation skills;
- Strong organizational and problem-solving skills with demonstrated project management abilities;
- Ability to deliver results, with the appropriate quality and timeline metrics;
- Good team leadership skills;
- Effective mentoring and training skills;
- Excellent customer service skills;
- Good judgment, with the ability to adapt and be proactive;
- Ability to manage competing priorities, and to sometimes work under pressure;
- Ability to establish and maintain effective working relationships with coworkers, managers and clients;
- Work ethic: always act according to good clinical practice and with ethical judgment;
- Easy-going: positive attitude, open-minded, smiling, resourceful and team-spirit;
- Startup environnement with a lot of challenge and innovation: no time for boredom;
- Share and learn everyday with world class talents who are experts in their field, and passionate about their daily work;
- Keep informed of all company progress with weekly and monthly meetings led by the CEO;
- Work in a great office in the city center of Paris(75003), and collaborate with our teams all over the world (Paris, NYC, Taipei);
- We are remote friendly;
- Bonus: good health cover “Alan”, Gymlib pass, Lunch card "Swile", BSCPE (only for full-time contracts);
- Our culture is reflected with our stellar Glassdoor rating : https://www.glassdoor.fr/Avis/Dreem-Avis-E1160223.html