MicroVentionTerumo

Clinical Research Manager, EMEA

Position Overview

The Clinical Research Manager is responsible for the management of clinical registries and train sites. He/She works closely with Director Clinical Research to handle operational issues at various sites and oversee the conduct of the studies conducted in EMEA. Job duties:
  • ­Work with the Director Clinical Research to set up a yearly clinical plan and budget for the project EMEA.
  • Manage company-sponsored and investigator-sponsored clinical studies in line with institutional, GCP, regulatory and compliance requirements.
  • Collaborate with study PIs, coordinate centers, CROs and/or sponsoring institutions to develop protocols, establish budgets, construct databases, select sites, set enrollment targets and implement enrollment and mitigation plans.
  • Work with legal team to facilitate preparation of clinical trial agreements, physician consulting agreements and other related contracts.
  • Assist Clinical Project Managers in study initiation and completion of clinical projects.
  • Interface with Monitors, sites and CRO’s to address and resolve study-related matters.
  • Provide status reports to Director Clinical Research as needed.
  • Ensure appropriate documentation is maintained.
  • Ensure clinical studies are conducted in accordance with EMEA local regulations.
  • Identify outside clinical vendors, set up contracting and purchase requests; coordinate ongoing maintenance of study contracts, budgets and financial reporting.
  • Contact person for clinical activities related to her/his projects assigned in EMEA.

Job Details

Job ID 12119BR

France

Apply for this job
    1. Bachelor’s degree in science or engineering.
    2. Five (5+) years experience in clinical research including regulatory compliance, quality assurance and/or quality engineering.
    3. Knowledge of MDD/MDR, EN ISO 13485: ISO clinical Research 14155:2020, ICH GCP and international regulatory requirements.
    4. Good interpersonal and management skills.
    5. Strong English language skills.
    6. Reading and preparing technical documentation.
    7. Excellent written and oral communication skills.
    8. Excellent time management skills.
    9. Proven ability to work independently as well as in a team environment.
    10. Ability to work with relevant computer software packages including MS Word and Excel.
    11. Ability to travel and participate in clinical meetings and other scientific conferences.
    12. Ability to work under time pressure while maintaining high standards of accuracy and project quality.
    Desired Qualifications
    1. ­Five (5+) years experience calling on Interventional Neuroradiologists preferred.