Position Overview

Manage project planning and communication with the study team to ensure the conduct of clinical studies in accordance with good clinical practices, MicroVention Standard Operating Procedures, and all applicable (e.g. FDA) regulations and guidelines. Involved in the design, conduct, data management, and interpretation and reporting of clinical trials. Ensure all clinical studies operate to the highest ethical and safety standards and in compliance with company, GCP and regulatory requirements. Job duties:
  • Contribute to the preparation of study documentation such as protocols, amendments, Case Report Forms, SOPs, investigational plans, Investigator’s manual, and study reports.
  • Collect and process regulatory documents and correspondence.
  • Prepare and ensure accuracy for MV studies on clinicaltrials.gov.
  • Assume other responsibilities under the direction of the Clinical Research department.
  • Perform additional duties as assigned.

    1. BS/BA degree in Life Sciences or related field.
    2. Two (2) to five (5) 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. MS office skills to include Word and Excel.
    Desired Qualifications
    1. Experience in designing, monitoring, and implementing clinical trials and interpreting trial results, including understanding of biostatistics and safety reporting.
    2. Able to handle multiple tasks efficiently and consistently, meeting deadlines.
    3. IDE clinical experience is strongly preferred, as well as global experience.
    4. Detail-oriented.
    5. Ability to maintain strict confidentiality