THE COMPANY:

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:

The Clinical Database Programmer is responsible for all technical aspects of clinical study database build, validation, and maintenance, including clinical programming activities for new and ongoing clinical studies, start-up activities, database revisions, timely resolution of technical issues related to the conduct and closeout of clinical studies. Database Programmer works collaboratively with Clinical Data Management, Clinical Operations, Statistical Programming and Biostatistics to complete programming tasks per agreed upon timelines.

  • Utilizes development tools to design Electronic data capture (EDC) system in clinical study databases and helps manage the lifecycle of the study database
  • Oversee activities related to external vendors supporting multiple trials to ensure consistency in data collection, transmittal and reporting
  • Works closely with Clinical Data Management to develop user requirements for EDC following CDISC/SDTM/CDASH format 
  • Facilitates activities regarding the design, development, testing, validation and implementation of the clinical study database
  • Facilitates test script development and performance of user acceptance testing including the testing of screens, edit check functionality, and user accounts/roles as necessary
  • Able to generate and maintain all required documentation, including specification versions, programming and validation efforts, in support of database build and maintenance
  • Drives post-production database changes to ensure compliance with protocol amendments and internal SOPs
  • Work with vendors on EDC and 3rd party system integration, data transfer specifications and perform external data loads as applicable, i.e., IxRS, central labs, ECGs, ePRO, etc.
  • Maintain MedDRA and WHO Drug dictionary repository and up version dictionaries, as applicable
  • Helps study team in data review activities by building reports or listings on a need basis
  • Participates in study close-out activities by managing database lock and access revocation 
  • Troubleshoots issues with EDC, working with the EDC vendor as needed
  • Liaises with the IT and QA groups to ensure tight communication, adequate support and quality of deliverables
  • Helps to develop and maintain standard library of eCRFs and edit checks in the database design tool
  • Helps develop database programming SOPs, work instructions and templates
  • Serves on project teams to coordinate and lead EDC development activities for clinical programming projects
  • Attends meetings, participates in discussions, uses an analytical approach to problem solving with a focus on quality deliverables
  • Helps ensure QC of deliverables related to study setup and maintenance in accordance with ICH-GCP, SOPs and standards
  • Provide mentorship to Database Programmers and Data Managers
  • Help provide EDC training to the study team and/or site 
  • Able to identify and escalate issues that may impact target dates or budget to management in a timely manner
  • Perform other technical duties as required

PERSONAL AND PROFESSIONAL QUALIFICATIONS:

Bachelor’s degree in health profession, computer science and/or engineering field

Minimum 3-5 plus years of clinical database programming experience, of which about 2-4 years of experience is in medical device and/or pharmaceutical database development/ data management environment

  • Good database programming skills with knowledge of SQL, SAS, relational databases, different EDC systems (Medrio, Medidata Rave, Oracle Clinical) setup experience preferred
  • Experience with reporting and Business Intelligence tools (e.g. Spotfire, Tableau, TOAD, Discoverer, Crystal Reports etc.) preferred
  • Comply with written procedures, instructions, SOPs and other documents
  • Team player work well in a team environment both as a leader and a key contributor
  • Excellent organizational skills and attention to detail
  • Ability to prioritize and multitask is required
  • Good written and verbal communication skills

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

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