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Senior Clinical Trial Manager

Company: JUUL Labs, Inc.
Location: San Francisco
Posted on: April 9, 2021

Job Description:

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: This position is accountable for-- clinical-- 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-- manage multiple clinical trials .-- This position reports to-- the-- Senior-- Director Clinical Operations.--

  • Responsible for managing and executing clinical studies .-- Develop and manage study timelines (including recruitment) and may develop and manage program timelines.
  • Ensure all trials are conducted in compliance-- with-- the study protocol,-- Good Clinical Practice (GCP), Good Laboratory Practice (GLP), the Declaration of Helsinki, and all applicable regulatory requirements.
  • Responsible for ensuring-- clinical study --data is generated, documented and reported in compliance-- with regulations --and study plans .
  • Participates in the selection of CRO/ investigational sites .-- Manages-- CRO activities, including project timelines & quality of deliverables, and managing approved trial-- budget(s) throughout the life of the assigned clinical trial(s) .--
  • Maintains frequent and meaningful contact with CROs to assess performance and provide guidance as needed . Provide or facilitate training to CRO on assigned protocol specific topics .
  • Responsible for-- staff management --including training,-- teambuilding,-- and-- mentoring .--
  • 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 timelines and compliance in alignment with overall clinical objectives.
  • Responsible for investigational-- product-- inventory, tracking, and reconciliation including distribution to and return from approved distribution centers and investigational sites.
  • Oversee the activities of local CRAs/CROs or perform monitoring activities.--
  • Contributes to-- development and finalization of-- study documentation including clinical protocols,-- informed consent forms,-- case report forms,-- clinical study reports as well as operational plans ( monitoring plan, project management plan, communication plan) .
  • Proactively identifies project risks and resolves with some supervision .
  • Participates in study data review and other review activities as assigned .
  • Oversees clinical trial sites' adherence to pertinent regulations through review of monitoring reports, CQA-GCP audit report, communications with investigators, study site personnel, CRAs, and other CRO/designee personnel .
  • Oversees the submission of trial-related and essential documents to the Trial Master Fil e,-- Investigator Site Files and patient records (at site and Sponsor) per company SOPs and in compliance with GCP, FDA and ICH guidelines .
  • Identifies and provides solutions to clinical trial issues and/or risks .
  • Represents Clinical Operations in cross-functional initiatives, as assigned by management, and may act on behalf of team when designated .
  • Works with CRO and Regulatory in filing of applications and responding to deficiencies
  • Participate in the clinical department SOP review and development.
  • Interact with cross-functional team to accomplish above responsibilities --Personal--and Professional Qualification and Education:
    • B achelor's or-- Master's --degree --in-- relevant scientific discipli ne with-- at least-- 8-10 years of-- clinical operations experience-- relevant industry experience at a CRO and/or pharmaceutical/biotech organization.
    • Thorough understanding of FDA, ICH and GCP guidelines
    • Experience with Phase I - I II --clinical trials
    • Proven track record showing clear proficiency in clinical project management skills
    • Proven complex-- problem-solving --skills
    • Prior experience managing direct reports is desirable--
    • Solid vendor management skills, e.g. CRO, Laboratory & Clinical supply logistics
    • Broad understanding of clinical operations related to clinical development functions
    • Ability to effectively interface with medical personnel at clinical site(s)
    • Ability to lead multi-disciplinary, cross-functional teams both internally & externally
    • Excellent interpersonal, verbal and written communication skills--
    • Proficiency with computer programs including Microsoft Office suite and Microsoft Project
    • Ability and willingness to travel-- 1 5% of the time-- 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 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 authorization to work for Juul Labs in the US. Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? --*
        -- Are you legally authorized to work in the location you are applying to? --*
        -- Do you have a family member who is an officer or employee of a government or public international organization? For purposes of this question, "family member" is defined as a parent/stepparent, grandparent, uncle/aunt, sibling/stepsibling or child/stepchild. --*
        -- If you answered yes to the question above, what is your relationship to the family member who is an officer or employee of a government or public international organization? (If you answered no to the question above, please select not applicable.) --*
        Not applicable
        What is the name of the government agency and their role? (Please enter "not applicable" if you don't have a family member who is an officer or employee of a government or public international organization.) --*
        Please verify that you are 21+ years old. --*
        Please select To learn about our information collection practices, including the categories of information we collect and how we use it, please read our Privacy Policy available at-- . For Example: LinkedIn, Website, Ad, Referral from existing Juul Labs employee (Include Full Name) U.S. Equal Opportunity Employment Information (Completion is voluntary) Individuals seeking employment at Juul Labs are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation. You are being given the opportunity to provide the following information in order to help us comply with federal and state Equal Employment Opportunity/Affirmative Action record keeping, reporting, and other legal requirements. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file. Gender Please select Are you Hispanic/Latino? Please select Race & Ethnicity Definitions If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows: A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability. A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service. An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense. An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985. Veteran Status Please select Form CC-305 OMB Control Number 1250-0005 Expires 05/31/2023 Voluntary Self-Identification of DisabilityWhy are you being asked to complete this form? We are a federal contractor or subcontractor required by law to provide equal employment opportunity to qualified people with disabilities. We are also required to measure our progress toward having at least 7% of our workforce be individuals with disabilities. To do this, we must ask applicants and employees if they have a disability or have ever had a disability. Because a person may become disabled at any time, we ask all of our employees to update their information at least every five years. Identifying yourself as an individual with a disability is voluntary, and we hope that you will choose to do so. Your answer will be maintained confidentially and not be seen by selecting officials or anyone else involved in making personnel decisions. Completing the form will not negatively impact you in any way, regardless of whether you have self-identified in the past. For more information about this form or the equal employment obligations of federal contractors under Section 503 of the Rehabilitation Act, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at . How do you know if you have a disability? You are considered to have a disability if you have a physical or mental impairment or medical condition that substantially limits a major life activity, or if you have a history or record of such an impairment or medical condition. Disabilities include, but are not limited to:
        • Autism
        • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, or HIV/AIDS
        • Blind or low vision
        • Cancer
        • Cardiovascular or heart disease
        • Celiac disease
        • Cerebral palsy
        • Deaf or hard of hearing
        • Depression or anxiety
        • Diabetes
        • Epilepsy
        • Gastrointestinal disorders, for example, Crohn's Disease, or irritable bowel syndrome
        • Intellectual disability
        • Missing limbs or partially missing limbs
        • Nervous system condition for example, migraine headaches, Parkinson's disease, or Multiple sclerosis (MS)
        • Psychiatric condition, for example, bipolar disorder, schizophrenia, PTSD, or major depression Disability Status Please select 1 Section 503 of the Rehabilitation Act of 1973, as amended. For more information about this form or the equal employment obligations of Federal contractors, visit the U.S. Department of Labor's Office of Federal Contract Compliance Programs (OFCCP) website at . PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

Keywords: JUUL Labs, Inc., San Francisco , Senior Clinical Trial Manager, Healthcare , San Francisco, California

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