Role OverviewWe are searching 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 office. Remote candidates may also be considered. The Clinical Research Manager will be responsible for executing and managing company-sponsored clinical trials, ensuring compliance with timelines and study milestones.
What You Will Do
The Clinical Research Manager will oversee the feasibility, selection, set up, conduct, and closure of clinical trials within allocated countries, in accordance with ICH-GCP, applicable legislation, and Company Standard Operating Procedures. They will also manage and oversee the ordering, tracking, and accountability of investigational products and trial materials.
Why It Might Be a Fit
This role requires a strong understanding of clinical research science and processes, as well as a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial regulations. The ideal candidate will have a minimum of 8 years of related scientific/technical experience, including leadership/management role within Clinical Research.
Requirements
- Minimum of a Bachelor’s Degree in Life Science, Physical Science, Nursing, or Biological Science
- 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
- Experience working well with cross-functional teams
- Experience with budget planning, tracking, and control
- Relevant industry certifications (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
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 period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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