Clinical Research Leader, Neurovascular

Role Overview

• Serves 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.
• Oversees/executes feasibility, selection, set up, conduct and closure of a clinical trial within the allocated countries, in accordance with the ICH-GCP, applicable legislation and Company Standard Operating Procedures.
• May serve as the primary contact for clinical trial sites (e.g. site management).
• Develops clinical trial documents (e.g. study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports).
• Ensures applicable trial registration from study initiation through posting of results and support publications as needed.
• Manages/oversees ordering, tracking, and accountability of investigational devices and trial materials.
• Interfaces and collaborates with site personnel, IRBs/ECs, contractors/vendors, and company personnel.
• Interfaces, collaborates and oversees Clinical Research Associates (CRAs).
• Oversees and supports the development and execution of Investigator agreements and trial payments.
• Responsible for clinical data review to prepare data for statistical analyses and publications.
• May perform monitoring activities including site qualification visits, site initiation visits, interim monitoring visits or close out visits based on study need.
• Contributes to the critical assessment of the literature and to the interpretations and disseminations of all evidence generated.

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