Clinical Research Manager
Johnson & Johnson MedTech, Irvine, CA, United States
Job Summary
Our MedTech Electrophysiology team is recruiting a Clinical Research Manager based in Irvine, CA, working a hybrid schedule of 2-3 onsite days per week. Under limited supervision, the Clinical Research Manager will lead a team of Clinical Research Leaders (CRLs) and Clinical Research Specialists (CRSs), ensuring the successful performance and delivery of project deliverables on time and with high quality while building positive relationships across the organization.
Key Responsibilities
Execute and manage company-sponsored clinical trials, ensuring 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, monitoring deviations, and data quality.
Oversee feasibility, selection, set-up, conduct, and close-out of clinical trials, ensuring adherence to ICH-GCP, applicable legislation, and Company SOPs.
Perform monitoring activities such as site qualification, site initiation, interim monitoring, and close-out visits.
Participate in device ordering, tracking, and accountability of investigational products and trial materials.
Collaborate with key stakeholders, including site investigators, IRBs/ECs, regulatory agencies, contractors/vendors, societies, and company personnel.
Provide input on clinical data review to prepare data for statistical analyses and publications.
Lead on-site procedural protocol compliance and data collection at clinical trial sites.
Deliver monitoring deliverables for assigned projects, partnering with the study core team to meet time, budget, and regulatory commitments.
Liaise with regional partners to ensure global standard processes are applied across the organization.
Plan, track, and manage assigned monitoring project budgets to adhere to business plans.
Ensure resources are available to provide quality deliverables while maintaining efficiency.
Act as a reliable, trusted resource of accurate, up-to-date project knowledge for stakeholders.
Develop a strong understanding of the pipeline, product portfolio, and business needs.
Manage work independently, solving problems that arise during trial execution and seeking guidance for complex issues.
Communicate business-related issues or opportunities to next management level.
Follow all Company guidelines related to Health, Safety, and Environmental practices and ensure compliance when supervising staff.
Ensure personal and Company compliance with all applicable regulations, policies, and procedures.
Perform other duties as assigned.
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
Masters degree with at least 7 years of clinical research experience; OR
PhD with at least 5 years of clinical research experience.
Previous experience managing or supervising global clinical trials.
Minimum of 2 years of leadership/management role within Clinical Research, including 1-2 years of people management.
Clinical project leadership across multiple studies/programs.
Experience working well with cross-functional teams.
Experience with budget planning, tracking, and control.
Medical device experience.
Preferred Qualifications
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.
Travel
This position may require up to 25% travel depending on the phase of the program.
Salary
$117,000.00 – $201,250.00
Benefits
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, 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 birth/adoption/foster care of a child
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
EEO 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. Johnson & Johnson actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
#J-18808-Ljbffr
Our MedTech Electrophysiology team is recruiting a Clinical Research Manager based in Irvine, CA, working a hybrid schedule of 2-3 onsite days per week. Under limited supervision, the Clinical Research Manager will lead a team of Clinical Research Leaders (CRLs) and Clinical Research Specialists (CRSs), ensuring the successful performance and delivery of project deliverables on time and with high quality while building positive relationships across the organization.
Key Responsibilities
Execute and manage company-sponsored clinical trials, ensuring 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, monitoring deviations, and data quality.
Oversee feasibility, selection, set-up, conduct, and close-out of clinical trials, ensuring adherence to ICH-GCP, applicable legislation, and Company SOPs.
Perform monitoring activities such as site qualification, site initiation, interim monitoring, and close-out visits.
Participate in device ordering, tracking, and accountability of investigational products and trial materials.
Collaborate with key stakeholders, including site investigators, IRBs/ECs, regulatory agencies, contractors/vendors, societies, and company personnel.
Provide input on clinical data review to prepare data for statistical analyses and publications.
Lead on-site procedural protocol compliance and data collection at clinical trial sites.
Deliver monitoring deliverables for assigned projects, partnering with the study core team to meet time, budget, and regulatory commitments.
Liaise with regional partners to ensure global standard processes are applied across the organization.
Plan, track, and manage assigned monitoring project budgets to adhere to business plans.
Ensure resources are available to provide quality deliverables while maintaining efficiency.
Act as a reliable, trusted resource of accurate, up-to-date project knowledge for stakeholders.
Develop a strong understanding of the pipeline, product portfolio, and business needs.
Manage work independently, solving problems that arise during trial execution and seeking guidance for complex issues.
Communicate business-related issues or opportunities to next management level.
Follow all Company guidelines related to Health, Safety, and Environmental practices and ensure compliance when supervising staff.
Ensure personal and Company compliance with all applicable regulations, policies, and procedures.
Perform other duties as assigned.
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
Masters degree with at least 7 years of clinical research experience; OR
PhD with at least 5 years of clinical research experience.
Previous experience managing or supervising global clinical trials.
Minimum of 2 years of leadership/management role within Clinical Research, including 1-2 years of people management.
Clinical project leadership across multiple studies/programs.
Experience working well with cross-functional teams.
Experience with budget planning, tracking, and control.
Medical device experience.
Preferred Qualifications
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.
Travel
This position may require up to 25% travel depending on the phase of the program.
Salary
$117,000.00 – $201,250.00
Benefits
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, 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 birth/adoption/foster care of a child
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
EEO 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. Johnson & Johnson actively seeks qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
#J-18808-Ljbffr