Johnson & Johnson MedTech · 3 days ago
Clinical Research Manager - JJMT Electrophysiology
Irvine, CA
Full-time
Hybrid
Mid, Senior Level
$117K/yr - $201K/yr
5+ years expJohnson & Johnson MedTech is a leader in healthcare innovation, focused on developing advanced solutions for complex diseases. The Clinical Research Manager will lead a team to ensure the successful execution of clinical trials, fostering positive relationships across the organization to deliver high-quality project outcomes.
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 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
Qualification
Required
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
OR PhD 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
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
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
Company data provided by crunchbase