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: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.
Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech
We are searching for the best talent for a
Clinical Research Manager to support our Electrophysiology business. This role will work a Flex/Hybrid schedule with 2-3 days per week onsite in our
Irvine, CA officeRemote candidates may also be considered.Responsibilities:Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Serves as a Clinical Research Manager within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones
- Has oversight of feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures;
- Manages and oversees ordering, tracking, and accountability of investigational products and trial materials;
- Ensures applicable trial registration (e.g. www.clinicaltrials.gov) from study initiation through posting of results and support publications as needed;
- Is responsible for team's interface and collaboration with key opinion leaders, investigators, IRBs/ECs, Regulatory agencies, contractors/vendors, societies, associations and company personnel;
- Is responsible for clinical data review to prepare data for statistical analyses and publications;
- May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need;
- In EMEA, responsible for Regulatory Affairs related tasks associated with clinical trials and evidence generation. (See ANNEX I - Regulatory Affairs Duties and Responsibilities);
- Contribute to the development and delivery of appropriate Global EGS (Evidence Generation Strategies)/ EDS (Evidence Dissemination Strategies) to support New Product Development and Life-Cycle Management, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access, R&D, etc), ensuring cross-functional alignment;
- Ensures input and strong alignment from key regional Clinical R&D leads and other strategically important countries/ regions in the development of the EGS/ EDS;
- Leads in study design to develop appropriate clinical trials to meet the clinical evidence needs;
- May provide on-site procedural protocol compliance and data collection support to the clinical trial sites;
- Leads in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, Abstracts, Manuscripts, Clinical Evaluation Reports, etc.;
- Is responsible for delivery of 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);
- Plans, tracks and manages assigned project budgets to ensure adherence to business plans;
- Contributes in clinical scientific discussions with regulatory agencies/ notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections;
- Serves as the clinical representative on a New Product Development team;
- Is responsible for development of Post-Market Clinical Follow-up (PMCF) Plans and Reports;
- Conducts review of promotional materials to ensure fair-balance, accuracy in clinical claims and messaging;
- Is 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;
- Manages and mentors resources assigned to designated clinical trials to provide quality deliverables while maintaining optimal efficiency;
- Is responsible for providing performance feedback to direct reports (if applicable) as well as coaching and assistance in their development;
- Is responsible for communicating business related issues or opportunities to next management level. Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
- Is responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies and procedures;
- 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.
- May perform other duties assigned as needed;
Education- Minimum of a Bachelor's Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
Experience- A minimum of 8 years related scientific/ technical experience, including leadership/ management role within Clinical Research.
- Significant previous experience in 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.
- Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, ...).
- Clinical/medical background is a plus.
- A minimum of 1-2 year people management related experience is a plus.
- Medical device experience is highly preferred.
Functional and Technical Competencies:- Thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations;
- Ability to provide scientifically strategic and scientific clinical research input across New Product Development and Life-Cycle Management projects, including complex and/ or transformational projects; Proven track record in delivering clinical projects within clinical/ surgical research setting, on time, within budget and in compliance to SOPs and regulations;
- Strong presentation and technical writing skills;
- Strong written and oral English communication skills;
- Comprehensive understanding of clinical trial regulations across multiple regions;
- Demonstrates competencies in the following area are required:
- Ability to lead teams to deliver critical milestones, including complex projects
- Strong project management skills with ability to handle multiple projects
- Strong people management skills
- Change agent in team development and progression
Leadership Competencies:Strong leadership required in alignment with J&J Leadership Imperatives:
- Connect - Develop strong collaborative relationships with key internal and external stakeholders to ensure development and timely delivery of innovative EGS/ EDS. Create strong and productive partnership with resource providers and vendors.
- Shape - Make recommendations for and actively participate and lead in departmental process improvement activities. Through efficient use of resources, shape the way clinical trial management is conducted and resources are utilized.
- Lead - Continually develop expertise to provide strategic and scientific clinical research capability. Ensure appropriate escalation of compliance issues.
- Deliver - Ensure all deliverables on allocated studies and those of any direct reports are met on time, within budget and in compliance to SOPs and regulations. Ensure all sponsored studies have appropriately trained clinical trial leaders/ specialists assigned.
Primary location for this position is Irvine, CA. At management discretion, the position may be performed remotely.
Ability to travel approximately 20-25% depending on the phase of the program.
#LI-Hybrid
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
