Serve as a Clinical Research Leader within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones.
Oversee/execute feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with ICH-GCP and applicable legislation.
Develop clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual).
Manage/oversee ordering, tracking, and accountability of investigational devices and trial materials.
Lead clinical data review to prepare data for statistical analyses and publications.
Act as primary contact for clinical trial sites and collaborate with site personnel, IRBs, and contractors/vendors.
Requirements
Minimum of a Bachelor’s Degree preferably in Life Science, Physical Science, Nursing, or Biological Science required.
BS with at least 6 years, MS with at least 5 years, PhD with at least 3 years of relevant experience preferred.
Previous experience in clinical research or equivalent is required.
Experience working well with cross-functional teams is required.
Relevant industry certifications preferred (i.e., CCRA, CCRC, CCRP, RAC, CDE, GCP, ISO 14155, MDR, MEDDEV,…).
Clinical/medical background is a plus.
Medical device experience is highly preferred.
Tech Stack
Google Cloud Platform
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