Clinical Research Leader

Johnson & Johnson Innovative Medicine • Irvine, CA

5d • $109,000 - $174,800 • Hybrid

About The Position

Johnson & Johnson MedTech Electrophysiology is recruiting a Clinical Research Leader for Biosense Webster, based in Irvine, California. The role leads the execution and management of company-sponsored clinical trials, ensuring timelines and study milestones are met and that studies comply with ICH-GCP, applicable legislation, and company standard operating procedures. The position oversees trials from feasibility and site selection through setup, conduct, and closure in assigned countries, and serves as the primary contact for clinical trial sites.

The Clinical Research Leader develops clinical trial documentation with minimal direction; oversees trial registration, results posting, investigational products, trial materials, agreements, payments, budgets, and clinical data review; and collaborates with sites, ethics committees, vendors, and internal teams. Depending on study needs, the role may conduct monitoring visits and provide on-site procedural protocol compliance and data-collection support. The leader partners with study teams to deliver clinical project commitments, contributes to evidence assessment and dissemination, and supports scientific discussions with regulatory agencies. The position generally operates with limited supervision, with guidance for complex situations.

The position requires on-site work in Irvine an average of up to 2–3 days per week and attendance at critical on-site meetings as scheduled. The anticipated base pay range is $109,000–$174,800. Listed time-off benefits include vacation, sick time, holidays, work/personal/family time, parental leave, bereavement leave, caregiver leave, volunteer leave, and military spouse time off, subject to applicable policies and eligibility.

Requirements

• Bachelor’s degree in Life Science, Physical Science, Nursing, Biological Science, or a related field and at least 6 years of clinical research experience; or a master’s degree in one of these fields and at least 5 years of clinical research experience; or a PhD in one of these fields and at least 3 years of clinical research experience.
• Experience with project or team leadership.
• Ability to work on-site in Irvine, California, an average of up to 2–3 days weekly, and attend critical on-site meetings as scheduled.

Nice To Haves

• Relevant industry certifications, such as CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, or MEDDEV.
• Medical device experience.
• CRO experience, site management, and clinical site monitoring experience.
• Experience delivering presentations and writing clinical reports.

Responsibilities

• Execute and manage company-sponsored clinical trials, ensuring compliance with timelines and study milestones.
• Oversee trial feasibility, site selection, setup, conduct, and closure in allocated countries in accordance with ICH-GCP, applicable legislation, and company standard operating procedures.
• Serve as the main contact for clinical trial sites.
• Develop clinical trial documents, such as protocols, informed consents, CRFs, monitoring plans, study manuals, investigator brochures, and annual reports, with minimal direction.
• Ensure trial registration from study initiation through results posting and support publications as needed.
• Oversee the ordering, tracking, and accountability of investigational products and trial materials.
• Communicate and collaborate with site personnel, IRBs/ECs, contractors, vendors, and company personnel.
• Lead development and execution of investigator agreements and trial payments.
• Lead clinical data review to prepare data for statistical analyses and publications.
• When applicable, perform site qualification, initiation, interim monitoring, and close-out visits.
• When applicable, provide on-site procedural protocol compliance and data-collection support to study centers.
• Contribute to literature assessment and interpretation and dissemination of generated evidence.
• Partner with the study core team to deliver clinical project commitments.
• Communicate business issues and opportunities to the next management level and provide accurate, current project knowledge to key team members.
• Manage assigned project budgets in accordance with business plans.
• Support clinical scientific discussions with regulatory agencies to advance clinical and regulatory strategy.
• Develop an understanding of the pipeline, product portfolio, and business needs.
• Serve as the clinical representative on the Product Development team.
• Ensure personal and company compliance with applicable federal, state, local, and company regulations, policies, and procedures.
• Follow company Health, Safety, and Environmental guidelines; where applicable, ensure supervised staff follow them and have necessary resources.
• Perform other duties as assigned.

Benefits

• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year, with different amounts for employees residing in Colorado or Washington.
• Holiday pay, including floating holidays: 13 days per calendar year.
• Work, Personal and Family Time: up to 40 hours per calendar year.
• Parental Leave: 480 hours within one year of a child’s birth, adoption, or foster care placement.
• Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior