Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Clinical Development & Research - Non-MD
Job Category:People Leader
All Job Posting Locations:Irvine, California, United States of America
Job Description:Our J&J MedTech Electrophysiology clinical team is currently recruiting for a
Clinical Research Manager. This role is located in Irvine, CA on a hybrid work schedule of 2 -3 days a week onsite.
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:- Minimum of a bachelor's degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 8 years clinical research experience is required
OR
Masters degree in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 7 years clinical research experience is required
ORPhD in Life Science, Physical Science, Nursing, or Biological Science or other related field with at least 5 years clinical research experience is required
- Previous experience in managing or supervising 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.
Other:- This position may require up to 25% travel depending on the phase of the program.
#PULSE #EP
Required Skills:Preferred Skills:Clinical Data Management, Clinical Evaluations, Consulting, Developing Others, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Inclusive Leadership, Leadership, Medicines and Device Development and Regulation, Operational Excellence, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research, Strategic Change, Study Management, Team Management
The anticipated base pay range for this position is :$117,000.00 - $201,250.00
Additional Description for Pay Transparency:
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
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 the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits
