Position Overview

Manage and oversee Clinical Research & Operations staff to ensure the effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting. Represent Clinical Research & Operations in a wide range of cross-functional groups, global functional committee(s), and initiatives intended to enhance function and company efficiency and productivity regionally and globally. Represent Clinical Research & Operations within Global Medical Affairs team to ensure ongoing collaboration and communication with internal stakeholders. Ensure adherence to SOPs, Good Clinical Practice, and FDA regulations. Job duties:
  • Develop infrastructure (e.g., resourcing, succession planning, and competencies) to support ongoing, acute, and long-term clinical research initiatives. Provide supervision, guidance, and leadership for Clinical Research Associates. Ensure effective recruiting, training, performance management, and development to team members to drive future growth and stability.
  • Direct, develop, and implement strategy vision of CR&O department to align with Medical Affairs.
  • 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 of products, study status, and outcomes.
  • Provide training to clinical sites on product use and 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 on corporate clinical research teams ensuring that colleagues are updated on all relevant issues.
  • Coach CRAs in various aspects of management (e.g., HR, budgets, resource allocation, etc.) 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, and adverse event reporting.
  • Manage staff directing the development implementation and evaluation of clinical studies.
  • Collaborate with New Product Development teams to determine pre-clinical and clinical feasibility requirements for new and existing products.
  • Travel as required (approximately 20%).
  • Perform other duties as assigned.

    1. Bachelor’s or master’s degree in Life Sciences or a related field.
    2. Fifteen (15+) or more years of experience in clinical research.
    3. Seven (7+) or more years of previous management experience.
    4. Experience with U.S. Class III (MDD) medical devices.
    5. Working knowledge of U.S. FDA, GCP, and IDE regulations.
    6. Extensive experience with all aspects of management of large clinical trials from inception to completion.
    7. Strong written and verbal communication and interpersonal skills; ability to coach and mentor.
    Desired Qualifications
    1. Well organized, analytical, and self-confident person.
    2. Strong researching abilities; experience conducting literature reviews and statistical analyses.
    3. Able to supervise/train internal resources (Associates) and external resources (contract monitors, etc.).
    4. Experience in neurovascular, cardiovascular, and/or peripheral vascular studies.