Clinical Research Leader - MedTech in Irvine

Johnson & Johnson MedTech

Irvine (CA)

On-site

USD 109,000 - 175,000

Full time

12 hours ago

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Job summary

Johnson & Johnson MedTech in Irvine, CA is seeking a Clinical Research Leader for the electrophysiology team. This on-site role will lead company-sponsored trials, ensuring timelines and milestones for Biosense Webster in compliance with ICH-GCP and regulatory requirements.

You will collaborate with site personnel, IRBs/ECs, vendors, and internal teams; develop trial documents; support trial registrations; monitor budgets; and contribute to data reviews and publications.

Qualifications

Minimum bachelor’s degree in Life Science or related field with at least 6 years clinical research experience; or Master’s with at least 5 years; or PhD with at least 3 years.
Experience with project/team leadership is required.
Relevant industry certifications are preferred (examples: CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV).

Responsibilities

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 ICH-GCP and company procedures.
Develop clinical trial documents (protocols, informed consents, CRFs, monitoring plans, manuals, investigator brochures).
Ensure trial registration from study initiation through posting of results (ClinicalTrials.gov).
Management/oversight of ordering, tracking, and accountability of investigational products and trial materials.
Collaborate with site personnel, IRBs/ECs, contractors/vendors, and company personnel.