Driving innovation to eliminate cigarettes
Clinical Project Lead
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 independent e-cigarette, selling over four million JUULpods per month. 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, 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:
This position is accountable for operational activities and executing all associated operations from start to finish, consistent with applicable regulations, guidelines, and policies. This position should be able to independently handle various clinical trial assignments.
* Responsible for clinical site activities which include site selection, regulatory submission, site start-up, enrollment and close-out. Working directly with local CRO/CRA and/or site (coordinator/PI(s)) to ensure timeliness and compliance in alignment with overall clinical objectives.
* Maintenance of Trial Master File, Investigator Site Files and patient records (at site and Sponsor) per company SOPs and in compliance with GCP, FDA and ICH guidelines.
* Support data management activities including review, querying, resolution and report generation for interim and final reporting; including for presentation, Annual reporting or regulatory submissions.
* Maintenance of study trackers including site regulatory, patient, monitoring, finance, insurance, training and CRF.
* Coordinate and prepare materials for Safety Reporting, Investigator/Coordinator meetings or trainings, and Core Lab activities. Assist or be responsible for conducting meetings, developing and/or refining procedures or managing related activities.
* Responsible for investigational device inventory, tracking, and reconciliation including distribution to and return from approved distribution centers and investigational sites.
* Responsible for study material and ancillary inventory at sites.
* Oversee the activities of local CRAs/CROs or perform monitoring activities.
* Support clinical specialist in case documentation at the site.
* Participate in the clinical department SOP review and development.
* Interact with cross-functional team to accomplish above responsibilities
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
EDUCATION: Bachelor’s Degree in a technical, scientific or health-related field.
* 3+ years of experience in clinical research management
* Excellent communication skills; including written, verbal and presentation.
* Excellent organizational skills and attention to details.
* Comfortable working multidisciplinary teams
* Strong data analysis skills.
* Action-oriented and motivated by results.
* Comfortable with ambiguity. Exemplifies integrity and strong values.
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
* Catered lunch, 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
Vapor, JUUL, Work Culture, Fast Paced, Start-up, Growth, Vape, Technology, Software, Hardware, Consumer Electronics, Manufacturing, Design, Product, Disruptive, Revolutionary, Cutting Edge, App, Android, eCommerce, B2C, San Francisco, Bay Area, IoT, San Jose, Los Angeles
Excellent medical, dental and vision benefits for you and your family.
With 4% matching.
Equity and performance bonuses. Every employee is a stakeholder in our success.
Snacks & drinks
Boundless snacks and drinks. Catered lunch daily.
Cell phone subsidy and commuter benefits.
A place to grow
We’ll help you set big goals, then watch you exceed them.
Work with talented, committed and supportive teammates.
JUUL Labs at a glance
JUUL Labs focuses on E-Commerce, Consumer Goods, B2B, Consumer Electronics, and Leisure. Their company has offices in San Francisco. They have a very large team that's between 1001-5000 employees. To date, JUUL Labs has raised $14.407B of funding; their latest round was closed on September 2019.