Position Overview

Responsible for the planning, conduct, management of assigned pre and post market clinical trials. Assist in the development of project timelines, budget, and overall clinical strategy with Clinical Management teams. Responsible for the ethical conduct of assigned clinical research trial(s) and communication with sites and team members to ensure the conduct of clinical trial(s) are in accordance with good clinical practices, MicroVention Standard Operating Procedures, and all applicable (e.g., FDA, FDAAA, ISO, EU MDR, etc.) regulations and guidelines. Accountable and/or responsible for various aspects of assigned clinical trial(s), including but not limited to: overall study and site activation and management, on-going data cleaning and monitoring, data management, developing study plans and critical table listings and figures, interpreting data, and reporting of clinical trials. Job duties:
  • Work with Clinical Research Management to define clinical study scope, project timelines, and budgets.
  • Conduct clinical studies in support of FDA approvals of company medical devices.
  • Provide resource, site and study management and monitoring support (e.g., SQV, SIV, IMV, SCV, training, etc.), and project operational support for on-going studies.
  • Manage the receipt and dissemination of study-related regulatory documents and correspondence from assigned sites and CRO for completeness and compliance with protocol and appropriate regulations.
  • Evaluate clinical data/information and provides interim and final reports as necessary to regulatory agencies, CT.gov, CMS, IRB, etc.
  • Provide support with post-clinical activities and product launch.
  • Contribute to the preparation of study documentation (e.g., protocols, Case Report Forms, SOPs, investigational plans, Investigator’s manual, etc.).
  • Manage the conduct of clinical studies in accordance with SOP, regulations, protocol, and guidelines.
  • Interface with monitors/CROs to address and resolve queries.
  • Work closely with Project Manager(s) to ensure clinical studies are conducted in accordance with the protocol, SOPs, and all applicable regulations.
  • Assist in writing clinical study reports by reviewing tables and listings generated from study data.
  • Perform additional responsibilities as assigned.

    1. BS/BA degree in Life Sciences or related field.
    2. One (1) to three (3) years of direct clinical research project management experience, preferably in the medical device industry.
    3. Demonstrated experience in project management.
    4. Knowledge of clinical trial design, management, terminology, and related GCP and regulatory requirements.
    5. Proficiency in the logistics of clinical study setup and management including study documentation development, site selection, budget development, IRB submission preparation, training, database oversight, and the tracking of study metrics.
    6. Familiarity with basic study design and logistical elements such as protocol construction, database/CRF development, contracts, informed consent, randomization, monitoring, and statistical plans.
    7. Strong verbal and written communication skills.
    8. Proficient with MS Office Suite (e.g., MS Project, VISIO, Outlook, PowerPoint, Word, Excel, etc.).
    9. Experience in EDC, eTMF, and CTMS systems.
    Desired Qualifications
    1. Experience in designing, monitoring, and implementing clinical trials and interpreting trial results.
    2. Able to handle multiple tasks efficiently and consistently, meeting deadlines.
    3. IDE clinical experience is strongly preferred.
    4. Detail-oriented.
    5. Ability to maintain strict confidentiality.
    6. Strong technical skills related to regulated Clinical Research process (Neurovascular or equivalent), project management, and systems.
    7. Ability to perform routine clinical trial activities with minimal supervision.
    8. Capability and flexibility to travel to hospitals and participate in training/clinical events.
    9. Clinical research expertise in various therapeutic areas (preferred areas: Neurovascular and/or Cardiovascular).
    10. Experience in the medical device industry preferred.
    11. FDA BIMO and Auditing experience, strongly preferred.