Clinical Data Manager
Science- Business Dev – Data /
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 90 experts is on a mission to beat insomnia and build the sleep medicine of tomorrow.
In the 5 years since Dreem’s creation, we’ve collected 1M nights of sleep data and helped thousands of people improve their sleep. We also accumulated 25 patents and 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 created a research network of 25 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, mechanical engineering, machine learning, electronic design, embedded systems, testing, ergonomics, development of proprietary applications and software, design, marketing and much more. Joining the team is challenging but hugely rewarding- working at Dreem means pushing the boundaries and being able to bring real positive change to people around the world. Ready to join the fight for better sleep?
Job Description:We are seeking a highly motivated individual to join us as a Clinical Data Manager. You will report to the Chief Science Officer of the company and work closely with the Clinical Operations team, Backend and algorithms and Quality teams in supporting our efforts in this exciting new area of digital biomarkers. The Clinical Data Manager is responsible for leading and overseeing all data management activities for in-house and outsourced clinical trials. He will be responsible for managing clinical data collection, and data review.
Responsibilities (include but are not limited to):
- Take responsibility within Dreem for ensuring we meet our pharma customer expectations for data management.
- Project level coordination and day to day oversight of Data Management tasks
- Handle data management timelines to ensure goals of teams are met
- Participate in Data Management infrastructure, by developing, and updating SOPs/work instructions development and cross-functional process improvement initiatives
- Drive and lead the development of all database design.
- Plan, develop and implement UAT, data specifications, data entry guidelines, CRF completion guidelines, and related operational manuals/guidelines.
- Generate automatic and manual queries, identifying and resolving inconsistencies in the output files.
- Handle day to day operations on the data pipeline alongside the backend and algorithm team.
- Review clinical data on an ongoing basis to ensure quality data
- Provide CDM expertise for collection, and cleaning to efficiently ensure high quality data.
- Manage CDM deliverables in coordination with internal and external cross functional teams.
- Maintain data integrity in compliance with GCP, relevant SOPs and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF)
- Analysis of the data and the preparation of interim and final reports.
- The archiving of study databases and related documents.
Essential Qualifications and Experience:
Master degree with 2+ years’ experience in data management or related fieldBachelor degree with 4+ years’ experience in data management or related fieldExperience with data management of wearable devices / digital health the technologies
Preferred Qualifications and Experience:
- Experience working for a CRO handling large amounts of digital data including from wearable devices.
- Early phase Clinical Development experienceDemonstrated knowledge of FDA, EMA, ICH guidelines and regulations covering clinical trials, statistics, and data management
- Familiar with scripting and automationExperience managing pharma customers – data transfer specification identification, ongoing communication regarding data receipt, and necessary updates as requested.
- Experience with database build, edit check programming, conduct data review and database lock
- Experience managing clinical data management deliverables for regulatory filings
- Excellent verbal and written communication skills, including the ability to clearly describe critical technical CDM aspects to non-CDM staff
- Flexible to changing priorities, detail-oriented, works well under pressure and able to take on unfamiliar tasks.
Dreem is a high growth, fast-paced organization. You will be working within a team of highly motivated, friendly, caring colleagues, at the intersection between the clinical operations and the backend.
Offices are based in the center of Paris.
A partial remote policy is put in place.
The ability to be productive and successful in an intense work environment is critical.
- Startup environnement with a lot of challenge and innovation: no time to boredom,
- Opportunity to create your own career: fast progression and job switch possible!
- Share and learn everyday with world class talents who are experts in their field and passionate about their daily work
- Kept informed of all progress of the company with weekly and monthly meeting led by the CEO,
- Work in great office in the city center and you will collaborate with our teams all over the world (Paris, NYC, Taipei)
- We are remote friendly
- You will be lucky to have the Dreem Headband whenever you want.
Bonus: good health cover “Alan”, Gymlib pass, Lunch card "Swile", BSCPE.
Our culture is reflected with a stellar Glassdoor rating : https://www.glassdoor.fr/Avis/Dreem-Avis-E1160223.htmBe