Clinical Research Manager - JJMT Electrophysiology
- Irvine, CA
- $115,000-197,800 per year
- Permanent
- Full-time
- 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
- 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
- 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.
- 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.
- This position may require up to 35% travel depending on the phase of the program.