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