Clinical Research Manager - JJMT Electrophysiology
- Irvine, CA
- $115,000-197,000 per year
- Permanent
- Full-time
- Oversees the study program, ensures compliance with procedures, monitors studies based on data need, identifies risks with appropriate escalation
- Drives prioritization within the research program based on strategic direction
- Ensures that timelines, risks and publications are tracked, validated and communicated
- Reviews the program dashboard and tracers, provides inputs as needed and synthesizes study level details into summaries
- Manages assigned study level execution for pre-market and post-market collaborative studies, including protocol development, cross functional collaboration for approvals, ensuring compliance for data collection, and data review.
- Represents the program in meetings as needed
- Provides leadership and oversight for scientific aspects of the program– study design review, literature search quality check, study level scientific accuracy in tracker and reports
- 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 and external researchers
- May liaise with regional partners to ensure global standard processes are shared and applied across the organization
- Functions as a reliable, trusted resource of accurate, up-to-date project knowledge as requested by key stakeholders;
- Has a strong understanding of the pipeline, product portfolio and strategic business needs
- Manages work 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
- 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
- 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.
- Sound knowledge of ICH-GCP, Clinical trial procedures
- 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.
- Primary location for this position is Irvine, CA. At management discretion, the position may be performed remotely.