Director, Clinical Research & Operations (GCP)

Position Overview

Responsible for clinical trials operations. Responsible for development, implementation and oversight of clinical research team managing clinical trials, clinical site management, the clinical monitoring process, and protocol development. Ensure adherence to SOPs, Good Clinical Practice and FDA regulations. Typical job duties might include:
  • Direct the development of systems, practices and processes to ensure efficient and effective clinical operations including clinical trial management, data analysis, final study report and publication.
  • Represent the business medical professionals involved in clinical research with the Company.
  • Develop and foster relationships with luminary physicians.
  • Collaborate with Marketing and R&D to organize workshops for meetings and regional MicroVention-sponsored symposia.
  • Monitor and report on clinical performance and products and study status and outcomes.
  • Provide training to clinical sites on product use, clinical procedures.
  • Manage budgetary requirements and ensure compliance of expenditures to meet budget for clinical programs.
  • Oversee clinical trial operations, including management of Contract Research Organization (CRO), clinical staff, and consultants.
  • Facilitate Investigator Meetings and Core Lab processes.
  • Oversee clinical trial operations, including IRB/Ethics committee approval, the provision of clinical trial materials (control of study devices), and overall operations management of the trial.
  • Ensure that all aspects of GCP are complied with at all times for all aspects of clinical trial through training at start-up and initiation meetings for clinical trials and ongoing SOP development and implementation.
  • Participate in corporate clinical research teams ensuring that colleagues are updated on all relevant issues.
  • Coache CRAs in various aspects of management (e.g. HR, budgets, resource allocation) that are relevant to particular project issues.
  • Implement training programs for CRAs and other contract clinical staff with topics that include: principles and practices of project management, team communication, computer software and IT training, protocol and CRF writing, adverse event reporting.
  • Manage staff directing the development implementation and evaluation of clinical studies.
  • Perform additional duties and responsibilities as assigned.

Job Details

    • Bachelor’s degree in Life Sciences or a related field.
    • Twelve (12) or more years of professional experience in clinical research.
    • Five (5) years of previous management experience.
    • Experience with U.S. Class III (MDD) medical devices.
    • Working knowledge of U.S. FDA, GCP, ISO and EU MDR regulations.
    • Extensive experience with all aspects of management of large clinical trials from inception to completion.
    • Strong written and verbal communication skills and interpersonal skills: ability to coach and mentor.
    • Proficient with MS Word, Excel, Outlook and Teams.
    • Travel up to 20% as needed
    Desired Qualifications
    • Master's degree in Life Sciences or related field.
    • Well organized, analytical and self-confident person.
    • Strong researching abilities and experience conducting literature reviews and statistical analyses.
    • Able to supervise/train internal resources (Associates), and external resources (contract monitors, etc.).
    • Experience in neurovascular, cardiovascular, peripheral vascular studies a plus.