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Clinical Research Manager

$117k - $201.25k

6010-Biosense Webster Inc. Legal Entity

Our J&J MedTech Electrophysiology clinical team is currently recruiting for a Clinical Research Manager located in Irvine, CA on a hybrid work schedule of 2-3 days a week onsite. Summary Under limited supervision, the Clinical Research Manager will lead a team of Clinical Research Leaders (CRLs) and Clinical Research Specialists (CRSs) to deliver project deliverables on time and with high quality. Key Duties and Responsibilities Execute and manage company‑sponsored clinical trials, ensuring monitoring compliance with timelines and study milestones. Provide leadership and oversight for monitoring activities, aligning them with study objectives and optimizing monitoring efficiency. Document and share insights into trial monitoring activities, including trends in protocol compliance, enrollment, and data quality. Oversee feasibility, selection, setup, conduct, and closure of clinical trials within allocated countries, following ICH‑GCP and company SOPs. Perform site qualification, initiation, interim, and close‑out visits. Manage device ordering, tracking, and accountability of investigational products and trial materials. Collaborate with key opinion leaders, investigators, IRB/ECs, regulatory agencies, contractors/vendors, societies, associations, and company personnel. Provide input on clinical data review for statistical analyses and publications. Lead on‑site procedural protocol compliance and data collection. Deliver monitoring deliverables within budget, on time, and in compliance with regulations and SOPs. Ensure global standard processes are shared and applied across the organization. Plan, track and manage monitoring project budgets to meet business plans. Maintain accurate, up‑to‑date project knowledge for stakeholders. Develop a strong understanding of the product pipeline, portfolio, and business needs. Act as a reliable, trusted resource for project knowledge. Work independently; solve problems arising during trial execution; seek guidance for complex issues. Communicate business issues or opportunities to management. Adhere to health, safety, and environmental practices per company guidelines. Qualifications Minimum of a bachelor’s degree in Life Science, Physical Science, Nursing, Biological Science, or related field with at least 8 years of clinical research experience, OR master’s degree with 7 years, OR PhD with 5 years. Previous experience managing or supervising global clinical trials. Minimum 2 years in a leadership/management role within clinical research, including 1‑2 years of people management. Experience leading multiple studies/programs and working cross‑functionally. Proficiency in budget planning, tracking, and control. Medical device experience. Preferred: bachelor’s degree (any of the above) and relevant industry certifications (CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO14155, MDR, etc.). Optional: clinical/medical background. Travel This position may require up to 25% travel, depending on the phase of the program. Compensation Anticipated base pay range: $117,000.00 – $201,250.00. Benefits Overview Vacation: 120 hours per calendar year. Sick time: 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents). Holiday pay: 13 days per calendar year, including floating holidays. Work, personal and family time: up to 40 hours per calendar year. Parental leave: 480 hours within one year of birth/adoption/foster care. Bereavement leave: 240 hours for an immediate family member, 40 hours for an extended family member per year. Caregiver leave: 80 hours in a 52‑week rolling period. Volunteer leave: 32 hours per calendar year. Military spouse time‑off: 80 hours per calendar year. For additional benefits information, visit Equal Opportunity Statement Johnson & Johnson is an 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, disability, protected veteran status, or other characteristics protected by federal, state, or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section503 of the Rehabilitation Act. #J-18808-Ljbffr

Vacancy posted 6 hours ago
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