Johnson & Johnson MedTech · 13 hours ago
Clinical Research Manager
Irvine, CA
Full-time
Hybrid
Senior Level, Lead/Staff
$117K/yr - $201K/yr
8+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, focusing on developing smarter and less invasive treatments. The Clinical Research Manager will oversee clinical trial management within the Clinical R&D Department, ensuring compliance with regulations and fostering collaboration across teams.
Hospital & Health Care
Responsibilities
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
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
Qualification
Required
Minimum of a Bachelor's Degree in Life Science, Physical Science, Nursing, Biological Science, or related scientific degree required
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
A minimum of 1-2 year people management-related experience is required
Preferred
Medical device experience is highly preferred
Experience with budget planning, tracking and control is preferred
Relevant industry certifications is preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, …)
Clinical/medical background is preferred
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
Benefits
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
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
Company
Johnson & Johnson MedTech
At Johnson & Johnson MedTech, we are working to solve the world’s most pressing healthcare challenges through innovations at the intersection of biology and technology.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Mike Walker
CFO & VP of Finance DePuy Synthes
Tino Schweighoefer, MBA
CFO Monarch Platform
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