Role Description
Johnson & Johnson MedTech, Neurovascular, is recruiting a Clinical Research Leader, Neurovascular, to join our team. This position is located in Irvine, CA. At management discretion, the position may be performed remotely.
Under minimal supervision, this Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while fostering strong, productive relationships with colleagues across the organization.
Duties & Responsibilities
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Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.
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Oversee/execute feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with ICH-GCP, applicable legislation and Company Standard Operating Procedures.
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May serve as the primary contact for clinical trial sites.
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Develop clinical trial documents (e.g., study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
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Ensure applicable trial registration from study initiation through posting of results and support publications as needed.
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Manage/oversee ordering, tracking, and accountability of investigational devices and trial materials.
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Interface and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
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Oversee and support the development and execution of Investigator agreements and trial payments.
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Responsible for clinical data review to prepare data for statistical analyses and publications.
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May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
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Contribute to the development and delivery of appropriate global evidence generation strategies (EGS) and evidence dissemination strategies (EDS).
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May provide on-site procedural protocol compliance and data collection support to the clinical trial sites.
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Contribute to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.
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Responsible for delivery of assigned clinical projects, through effective partnership with the study core team.
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Support planning, track and manage assigned project budgets to ensure adherence to business plans.
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Support clinical scientific discussions with regulatory agencies/ notified bodies.
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May serve as the clinical representative on a New Product Development team.
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May assist with the development of Post-Market Clinical Follow-up (PMCF) Plans and PMCF Evaluation Reports (ER).
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May conduct review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging.
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Manage and/or mentor resources assigned to designated clinical studies.
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Function as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders.
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Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
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Perform other duties assigned as needed.
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May act as Clinical Safety Coordinator, coordinating all safety-related activities of clinical trials.
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Strategic planning and coordination of all new safety initiatives.
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Development of clinical study safety management plan (SMP) and study-specific safety flow.
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Cooperate with necessary stakeholders on safety activities related to clinical studies.
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Coordinate the collection of required information on safety events with the clinical study team.
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Ensure timely database notifications to relevant parties.
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Ownership of the study safety inbox and coordination of timely reporting of study adverse events.
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Create safety reports for reporting to internal stakeholders, investigators, ethics committees and authorities.
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Coordinate safety board meetings and act as point of contact for any questions.
Qualifications
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Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science or closely related degree.
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BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.
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Previous experience in clinical research or equivalent is required.
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Experience working well with cross-functional teams is required.
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Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
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Clinical/medical background is a plus.
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Medical device experience is highly preferred.
Requirements
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Good understanding of clinical research science and processes along with an understanding of product development processes.
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Ability to provide scientifically strategic and scientific clinical research input across New Product Development (NPD) and Life-Cycle Management (LCM) projects.
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Proven track record in delivering clinical projects within clinical/surgical research setting, on time, within budget and in compliance to SOPs and regulations.
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Strong presentation and technical writing skills.
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Strong written and oral English communication skills.
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Demonstrate competencies in behaving and leading in a professional and ethical manner.
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Advanced project management skills with ability to handle multiple projects.
Benefits
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Vacation – 120 hours per calendar year.
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Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year.
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Holiday pay, including Floating Holidays – 13 days per calendar year.
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Work, Personal and Family Time - up to 40 hours per calendar year.
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Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child.
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Bereavement Leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year.
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Caregiver Leave – 80 hours in a 52-week rolling period.
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Volunteer Leave – 32 hours per calendar year.
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Military Spouse Time-Off – 80 hours per calendar year.
