Clinical Research Manager - JJMT EP

Clinical Research Manager

Johnson & Johnson MedTech - Electrophysiology division is currently seeking a Clinical Research Manager. The role's preferred location is Irvine, California however we are open to remote candidates within the United States. While specific cities are listed in the Locations section for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply.

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Cardiovascular? Ready to join a team that's reimagining how we heal? Our Cardiovascular team develops leading solutions for heart recovery, electrophysiology, and stroke. You will join a proud heritage of continually elevating standards of care for stroke, heart failure and atrial fibrillation (AFib) patients.

Summary : Under limited supervision, this Clinical Research Manager will provide leadership to a team of Clinical Research Leaders (CRLs) and Clinical Research Specialists (CRSs) and ensure the successful performance and delivery of project deliverables, on time with high quality. The Clinical Research Manager will be responsible for encouraging strong, positive relationships with co-workers 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 - Electrophysiology
• 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 standard processes 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 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 :

Required Education & Skills / Experience :

Preferred Education & Skills / Experience :

Other :

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. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center (ra-employeehealthsup@its.jnj.com) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is $115,000 - $197,000. Additional Description for Pay Transparency : 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.