Biosense Webster, part of the Johnson & Johnson family of companies, is recruiting a Clinical Research Leader, located in Irvine, CA.
Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.
Clinical Research Leader will be responsible for leading and supporting one or several clinical trials within the Clinical R&D Department while encouraging strong, positive relationships with co-workers across the organization.
- Serve as a Clinical Research Lead to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones, for Biosense Webster.
- Oversight/execution of feasibility, selection, set up, conduct and closure of the trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
- Serves as the main contact for clinical trial sites (e.g. site management).
- Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal direction.
- Ensure trial registration from study initiation through posting of results and support publications as needed; (e.g. on www.clinicaltrials.gov)
- Management/oversight of ordering, tracking, and accountability of investigational products and trial materials.
- Communicate and collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
- Lead all aspects of development and execution of Investigator agreements and trial payments.
- Leads clinical data review to prepare data for statistical analyses and publications.
- If applicable, may perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
- If applicable, as part of a clinical study, may provide on-site procedural protocol compliance and data collection support to the center.
- Contribute to the assessment of the literature and to the interpretations and disseminations of all evidence generated.
- Responsible for clinical projects, through partnership with the study core team leading to delivery of clinical project commitments.
- Responsible for communicating business related issues or opportunities to next management level. Function as a trusted resource of accurate, up-to-date project knowledge as requested by key team member.
- Supervise and manage assigned project budgets to ensure adherence to business plans.
- Support clinical scientific discussions with regulatory agencies to drive support of the clinical and regulatory strategy.
- Develop a strong understanding of the pipeline, product portfolio and business needs.
- Serve as the clinical representative on the Product Development team.
- Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures.
- Manage resources assigned to designated clinical studies to provide quality results while maintaining efficiency.
- Generally, manages work with limited supervision, dependent on project complexity. Independent decision-making for simple and more sophisticated situations with minimal mentorship.
- Frequent (several times per month) interaction with physicians and research staff at centers selected for involvement in clinical studies as well as those being evaluated.
- Regular interaction with third party vendors supporting clinical trials as applicable per program.
- Additional related duties maybe assigned
- Minimum of a bachelor’s degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 6 years clinical research experience is required
Masters degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 4 years clinical research experience is required
PhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 3 years clinical research experience is required
- Experience with clinical trial project leadership or project management is required
- Relevant industry certifications are preferred (examples may include CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).
- Medical device experience highly preferred
- CRO experience and site management and clinical site monitoring are assets
- Experience delivering presentations and writing clinical reports is preferred
- This position will require on-site work in Irvine, CA, on average up to 2-3 days weekly, as well as attendance at critical on-site meetings as scheduled.
- Ability to travel up to 25%, international or domestic, is required
Do you want to be part of a diverse team delivering innovative products to market? Apply today!
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.