Temporary Clinical Monitor  

The role includes monitoring activities at both local and international clinical sites, ensuring compliance with Good Clinical Practices (GCP), study protocols, and regulatory requirements. The position requires frequent travel, strong communication skills, and the ability to collaborate effectively with investigators, clinical staff, and internal teams.

Key Responsibilities:

Clinical Monitoring Activities

• Conduct site-opening visits and train site personnel on study protocols and procedures (Study Initiation Visits).
• Set up study centers, including onsite device installation, and verify availability of required documentation.
• Performperiodic on-sitemonitoringvisits (RoutineMonitoringVisits)to:
  • Verify that informed consent was properly signed and dated before any study procedure.
  • Ensure accuracy, completeness, and authenticity of study data.
  • Confirm protocol adherence, GCP compliance, and alignment with regulatory requirements.
  • Export data from study devices according to study procedures.
• Promptly communicate any serious deficiencies to the appropriate parties.
• Collaborate with clinical research staff and investigators to address issues and improve site performance.
• Maintain accurate records of monitoring reports, correspondence, and documentation according to internal procedures.
• Participate in internal meetings, training activities, and audits/inspections when required.
• Conduct site close-out visits at study completion.

Communication & Operational Coordination

• Act as the primary communication link between the sponsor and investigative sites.
• Provide continual support to investigators, addressing queries and advising on issue resolution.
• Participate in operational meetings with investigators, coordinators, and monitors to maintain engagement and study compliance.
• Provide detailed reports to the study team and Head of Clinical Research following each visit, as well as periodic updates.

Data Management & Study Support

• Export, clean, validate, and manage study data according to the protocol; perform data entry when needed.
• Monitor data collection remotely and maintain active communication with study sites.
• Organize and participate in periodic meetings to review study progress.
• Support the R&D Clinical team in preparing and editing study documentation.
• Perform verification activities on medical devices involved in the study.
• Support the development and implementation of spontaneous studies, including follow-up and communication with researchers/clinicians.

Scientific & Cross-Functional Activities

• Participate in and promote educational events (e.g., conferences, seminars) to remain current in clinical research practices.
• Collaborate with Business Line and R&D teams to identify new product requirements based on clinician feedback and clinical evidence.
• Serve as a key interface for external stakeholders, including KOLs, CROs, principal investigators, and research staff.

Project Management

• Support project planning and execution related to clinical activities.
• Ensure accurate, timely, and compliant conduct of clinical studies in alignment with GCP and internal quality management systems.

Qualifications:

Education & Technical Skills

• Bachelor's Degree in Engineering
  
• Excellent command of English (written and spoken).
  
• Strong proficiency in Microsoft Office.
• Programming skills in MATLAB, Python, or R (preferred).
• Basic statistical data analysis capabilities.
• Knowledge of clinical study protocols and conduct of clinical trials (preferred).
• Experience in the medical device industry and/or monitoring activities.
• Knowledge of EU MDR 745/2017 and ISO 13485 (preferred).
• Familiarity with ISO 14971 risk management (preferred).
• Experience with ophthalmic diagnostic equipment (preferred).
• Understanding of product management and marketing principles (preferred).

Skills

• Willingness and ability to travel frequently.
• Excellent organizational and time-management skills.
• Strong communication abilities; cooperative and supportive work style.
• Reliability, flexibility and a proactive attitude toward problem solving.

The company is a well-established entity within the biomedical industry, known for its commitment to advancing healthcare solutions.

Temporary contract, 1 year.