Clinical Research Manager

About the Role

Johnson & Johnson MedTech, a leader in healthcare innovation, is seeking a dynamic Clinical Research Manager to join our team in Irvine, CA. This role offers the opportunity to lead a talented team in the successful execution and management of pivotal clinical trials, while cultivating strong relationships across the organization.

As a Clinical Research Manager within the Clinical R&D Department for JNJ MedTech - Electrophysiology, you will be instrumental in executing and overseeing company-sponsored clinical trials. Your responsibilities will include ensuring compliance with timelines and study milestones, providing leadership and oversight for monitoring activities, and contributing to trial design to optimize efficiency and effectiveness.

You will document and share insights into trial monitoring activities, collaborating with external partners like principal investigators and support staff, as well as internal stakeholders including the study team, management, and leadership. Your expertise will be crucial in contributing to the oversight of feasibility, selection, setup, conduct, and closure of clinical trials across allocated countries, adhering to ICH-GCP, applicable legislation, and Company Standard Operating Procedures.

Key responsibilities include performing monitoring activities such as site qualification, initiation, interim monitoring, and close-out visits. You may also be involved in the management and oversight of device ordering, tracking, and accountability of investigational products and trial materials. Furthermore, you will interface and collaborate with key opinion leaders, site investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations, and company personnel.

This role requires providing input on clinical data review to prepare data for statistical analyses and publications, and leading on-site procedural protocol compliance and data collection at clinical trial sites. You will be responsible for the delivery of monitoring deliverables for assigned clinical projects, ensuring timely, within-budget, and compliant execution through effective partnership with the study core team. Collaboration with regional partners to ensure global standard processes are shared and applied is also expected.

Budget management, resource allocation, and acting as a trusted resource for project knowledge are vital. Developing a strong understanding of the pipeline, product portfolio, and business needs is essential. Independent problem-solving is encouraged, with guidance sought for more complex issues. You will communicate business-related issues or opportunities to management and ensure adherence to all Company guidelines related to Health, Safety, and Environmental practices, as well as all Federal, State, local, and Company regulations, policies, and procedures.

Key Responsibilities

• Execute and manage company-sponsored clinical trials, ensuring compliance with timelines and study milestones for JNJ MedTech - Electrophysiology.
• Provide leadership and oversight for clinical trial monitoring activities, aligning with study objectives and contributing to trial design optimization.
• Document and share insights into trial monitoring activities, trends, and deviations.
• Contribute to the oversight of trial lifecycle stages (feasibility to closure) in allocated countries, adhering to global standards and regulations.
• Perform various site monitoring visits (qualification, initiation, interim, close-out).
• Manage and oversee investigational product and trial material logistics (ordering, tracking, accountability).
• Interface and collaborate with external and internal stakeholders including KOLs, investigators, regulatory bodies, and company personnel.
• Provide input on clinical data review for analyses and publications.
• Lead on-site procedural protocol compliance and data collection at trial sites.
• Deliver monitoring responsibilities for assigned projects, ensuring timely, budget-compliant, and regulatory adherence.
• Liaise with regional partners to ensure global process consistency.
• Plan, track, and manage assigned monitoring project budgets.
• Ensure efficient and quality delivery of monitoring activities through effective resource management.
• Serve as a reliable source of project knowledge for key stakeholders.
• Develop a strong understanding of the product pipeline and business needs.
• Independently manage work and solve problems, seeking guidance when necessary.
• Communicate business issues and opportunities to management.
• Ensure adherence to all Health, Safety, Environmental, and regulatory guidelines.

Qualifications

Must Have:

• Bachelor's degree in Life Science, Physical Science, Nursing, or a related field with at least 8 years of clinical research experience; OR Master's degree with at least 7 years; OR PhD with at least 5 years.
• Previous experience managing or supervising global clinical trials.
• A minimum of 2 years in a leadership/management role within Clinical Research, including 1-2 years of people management experience.
• Clinical project leadership across multiple studies/programs.
• Proven experience working effectively with cross-functional teams.
• Experience with budget planning, tracking, and control.
• Medical Device experience is mandatory.

Preferred:

• Bachelor's Degree in Life Science, Physical Science, Nursing, or Biological Science.
• Relevant industry certifications (e.g., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR).
• Clinical/medical background is a plus.

Benefits

• Consolidated retirement plan (pension) and savings plan (401(k)).
• Vacation: 120 hours per calendar year.
• Sick time: 40 hours per calendar year (varies by state).
• 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 child's birth/adoption/foster care.
• Bereavement Leave: 240 hours for immediate family, 40 hours for extended family.
• 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.