Summary

Under limited supervision, this Clinical Research Manager will provide leadership to a team of Clinical Research Associates (CRAs) and ensure the successful performance and delivery of project deliverables, on time with high quality. The Clinical Research Manager will be responsible for fostering strong, productive relationships with colleagues across the organization.

Key Duties/Responsibilities

• Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring monitoring compliance with timelines and study milestones for JNJ MedTech - Neurovascular

• Provide leadership and oversight for monitoring activities of clinical trials, aligning activities with broader study objectives, and providing input on trial design to optimize monitoring efficiency and effectiveness;

• Experience documenting and sharing insights into trial monitoring activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality); external partners e.g. principal investigators and support staff, and internal partners e.g. study team, management and leadership staff;

• Contribute to the oversight of feasibility, selection, set up, conduct and closure of a clinical trial as related to monitoring activities within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;

• Perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits;

• May be involved in the management and oversight of device ordering, tracking, and accountability of investigational products and trial materials;

• May be involved in the team's interface and collaboration with key opinion leaders, site investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations 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 to the clinical trial sites;

• Is responsible for delivery of monitoring deliverables for assigned clinical projects, through effective partnership with the study core team leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and SOPs);

• May liaise with regional partners to ensure global best practices are shared and applied across the organization;

• Plans, tracks and manages assigned monitoring project budgets to ensure adherence to business plans;

• Ensures resources assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency;

• Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;

• Should develop a strong understanding of the pipeline, product portfolio and business needs;

• Manages work independently. Independently solves problems arising during clinical trial execution, and will seek guidance for more complex problems, as needed;

• Responsible for communicating business related issues or opportunities to next management level;

• Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable;

• For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable;

• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures;

• Performs other duties assigned as needed;

Qualifications

Qualifications

Required Education & Skills/Experience:

• A minimum of a BA/BS Degree

• A minimum of 8 years relevant experience in the healthcare field

• Previous experience in managing or monitoring global clinical trials

• A minimum of 2 years leadership / management role within Clinical Research including 1-2 years of people management experience is required.

• Clinical project leadership across multiple studies/ programs is required.

• Experience working well with cross-functional teams is required.

• Experience with budget planning, tracking and control is required.

• Medical Device experience is required.

Preferred Education & Skills/Experience:

• Bachelor's Degree in Life Science, Physical Science, Nursing, or Biological Science is preferred.

• Relevant industry certifications are preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, ...).

• Clinical/medical background is a plus.

• Neurovascular experience is preferred.

Other:

• This position may require up to 25-35% depending on the phase of the program.

• Primary location for this position is Irvine, CA. At management discretion, the position may be performed remotely.

The anticipated base pay range for this position is 113000 to 195500.

California Bay Area - The anticipated base pay range for this position is 139000 to 224825.

The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. •

Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company's long-term incentive program.

Employees are eligible for the following time off benefits:

• Vacation - up to 120 hours per calendar year

• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year

• Holiday pay, including Floating Holidays - up to 13 days per calendar year

• Work, Personal and Family Time - up to 40 hours per calendar year

• Additional information can be found through the link below.

https://www.careers.jnj.com/employee-benefits

The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market."

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

This job posting is anticipated to close on 11/29/2024. The Company may however extend this time-period, in which case the posting will remain available on https://www.careers.jnj.com to accept additional applications.