JUUL Labs’ mission is to impact the lives of the world’s one billion adult smokers by eliminating combustible cigarettes. We have the opportunity to address one of the world’s most intractable challenges through a commitment to exceptional quality, research, design, and innovation. Backed by leading technology investors, we are committed to the same excellence when it comes to hiring great talent.
We are a diverse team that is united by this common purpose and we are hiring the world’s best engineers, scientists, designers, product managers, operations experts, and customer service and business professionals. If the opportunity to build your career at one of the fastest growing companies is compelling, read on for more details.
ROLE AND RESPONSIBILITIES:
The role of a Senior Clinical Data Manager (Sr. CDM) at JUUL Labs (JUUL) entails leading, performing, and overseeing all Data Management (DM) activities for assigned Clinical studies. It also requires the Sr. CDM to function collaboratively with multi-disciplinary team to undertake ownership of, and to drive timeliness of delivery and quality of JUUL clinical study data for regulatory submissions and/or for driving product related business decisions.
Reporting to the Director, Clinical Data Management, a Sr. CDM assumes ownership and responsibility towards-
- Leading and overseeing, and where applicable performing, end to end DM activities from Study start-up, conduct and close-out of assigned clinical trials to deliver data for analysis
- Timely documentation and delivery, and/or DM CRO oversight, of all applicable DM deliverables including, but not limited to, Case Report Form (CRF) design, database build requirements, Edit Checks design, User Acceptance testing (UAT), maintenance plans such as Data Management Plan (DMP), Data Review Plan (DRP), lock approvals
- Interacting with Clinical Operations, Statistical Programmers, and Biostatisticians in designing CRFs and CRF completion guidelines
- Leading the interactions with CROs and third-party vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data and data transfer specifications
- Performing coding review for Adverse Events (AEs), Medical History and Concomitant Medications and coordinate Medical Monitor review and approval of medical coding
- Performing and overseeing data cleaning, discrepancy management and vendor data reconciliation (e.g. SAE, Lab, PK, ECG etc.) activities to ensure data collected meets the requirements of the study objective and quality standards
- Participating in the review of clinical study protocol and other study documents like Clinical Monitoring Plan, Protocol Deviation Management Plan, and Statistical Analysis Plan
- Developing and executing procedures for data quality review and data acceptance prior to data analyses and/or database lock
- Ensuring completeness, correctness and consistency of clinical data and data structure across all clinical trials
- Managing study records related to DM are filed in the Trail Master File in a timely basis
- Participating in clinical review and validation of statistical outputs used in the preparation of final reports, protocols, and publications
- Working with Biostatistician and other departments to assist Regulatory submission of Clinical research data and addressing all questions
- Supporting cross-functional collaboration to meet study requirements for one or more study related activities
- Training members of the study team, site(s), CRO(s) on DM related functionalities and operations pertaining to the study in conduct, when required
- Developing and maintaining DM Standard Operating Procedures (SOPs), work instructions, training guides etc., and contribute to the content for other departmental standards or policies
- Evaluating internal DM processes and applications for improvements; participating in working groups in establishment, and eventual improvement, of DM infrastructure
- Assisting in on-boarding, coaching or mentoring new team members, including on-site consultants
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- 5+ years of clinical trials data management experience in the Pharmaceutical, Biotechnology, Medical Device or Diagnostic industry
- 2+ years of DM vendor(s)/CRO Management experience
- Experience with Electronic Data Capture (EDC) systems such as Medrio, Inform and Medidata Rave
- Experience with/working knowledge of data cleaning/review tools and/or data visualization tools (such as Business Objects, J-Review, Spotfire)
- Thorough knowledge of FDA regulations, ICH GCP guidelines, and industrial standards such as SDTM, CDISC, CDASH etc.
- Excellent communication and organizational skills, along with problem solving, conflict resolution, leadership and team-building skills
- Experience in managing multiple studies and being able to work in a fast-pace environment
- Has good project management skills and a proven ability to multitask
- Bachelor’s or Master’s degree in Life Science, Pharmaceutical Science or a 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
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.