JUUL's mission is to improve the lives of the world’s one billion adult smokers by driving innovation to eliminate cigarettes. JUUL is the number one US-based vapor product. Headquartered in San Francisco and backed by leading technology investors including Tiger Global, Fidelity Investments and Tao Invest LLC, JUUL Labs is disrupting one of the world’s largest and oldest industries.
We’re an exceptional team with backgrounds in technology, healthcare, CPG and biotech, and we’re growing rapidly to deliver on our mission. We’re actively looking to hire the world’s best scientists, engineers, designers, product managers, supply chain experts, customer service and business professionals.
ROLE AND RESPONSIBILITIES:
JUUL Labs (JUUL) Senior Clinical Data Manager roles are primarily accountable for the acquisition, transit, cleaning and overall quality of JUUL clinical study data from Phase 1 through regulatory submissions. Ability to interact collaboratively, cross-functionally, in external partnerships and oversee CROs is a critical responsibility. Knowledge of Industry and regulatory standards (CDISC, SDTM) with an ability to translate clinical team objectives into operational actions maximizing the current technical platforms will be a heavily leveraged skill set. Pharmaceutical, medical device or research settings experience is a plus.
Reporting to the Director, Data Management, provides oversight for data management projects and products.
- Manages data activities for all clinical trials (Phase I - IV) as well as the design, review, and validation of the clinical database to deliver data for analysis and submission as part of a regulatory filing.
- Designs case report forms (CRFs) as well as data edit checks and aggregate check specifications with CROs.
- Will oversee the development of any clinical database by the EDC/CRO vendor, and will manage the sponsor user acceptance testing of the clinical database.
- Works in coordination with statisticians and programmer/analysts.
- Works in coordination with clinical research and development, clinical operations, and CROs to develop study documents including the study protocols, (CRFs), and CRF instructions.
- Primary interface with CROs for any data management related activities.
- Ensures that data management tasks remain on target according to study timelines and requirements.
- Proactively works with CROs to organize on-going data review throughout the study to ensure timely identification and correction of errors or discrepancies.
- Routinely communicates site data concerns/issues with clinical operations team and CROs in order to ensure collaboration toward resolution.
- Ensures delivery of a quality locked database for analysis at the close of studies.
- Experience with vendor management required
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 5+ years of clinical trial data management experience in the biopharma or medical device industry.
- Experience with clinical databases such as Medrio, Medirave, Clindata, Oracle
- Strong understanding of clinical trial process and EDC platforms.
- Experience with data programming tools and/or data viewing tools (J-Review, SAS JMP.etc).
- Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills.
- Pharmaceutical or Medical Device research experience.
- Global trial experience.
- A high degree of flexibility and the willingness to take on non-traditional CDM task is important in smaller start-up companies.
- Bachelor’s degree or equivalent combination of education/experience in math, science or health-related field.
JUUL LABS PERKS & BENEFITS:
- A place to grow your career. We’ll help you set big goals - and exceed them
- People. Work with talented, committed and supportive teammates
- Equity and performance bonuses. Every employee is a stakeholder in our success
- Boundless snacks and drinks
- Cell phone subsidy, commuter benefits and discounts on JUUL products
- Excellent medical, dental and vision benefits
- Location. Work in the heart of San Francisco, one of the world’s greatest cities
JUUL Labs is proud to be an equal opportunity employer and is committed to creating a diverse and inclusive work environment for all employees and job applicants, without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. We will consider for employment qualified applicants with arrest and conviction records, pursuant to the San Francisco Fair Chance Ordinance. JUUL Labs also complies with the employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have the authorization to work for JUUL Labs in the US.