all activities comply with SOPs and regulatory requirements.
• Perform Source Document Verification (SDV), review ICFs, oversee eCRF completion, and ensure SAE reporting accuracy.
• Collaborate with investigators to ensure adherence to protocols, regulatory...
all activities comply with SOPs and regulatory requirements.
• Perform Source Document Verification (SDV), review ICFs, oversee eCRF completion, and ensure SAE reporting accuracy.
• Collaborate with investigators to ensure adherence to protocols, regulatory...
all activities comply with SOPs and regulatory requirements.
• Perform Source Document Verification (SDV), review ICFs, oversee eCRF completion, and ensure SAE reporting accuracy.
• Collaborate with investigators to ensure adherence to protocols, regulatory...
POSITION SUMMARY:
The Senior Clinical Research Associate (Senior CRA) is responsible for scheduling and conducting on-site and remote monitoring visits in compliance with applicable regulatory standards (MDR, ISO 14155, ICH/GCP guidelines, Teleflex...
and stay updated on industry trends
• Keeps account/customer/information data in CRM.
• Share learning/insights with team members, managers, and cross-functional partners. Identifies business opportunities and together with his manager.
Regulatory and / or...
adequately trained in identifying and reporting AEs/SAEs
• Checks that all submissions, reports, notifications and applications to the IEC/IRB or Regulatory Authorities have been made by the Investigator in a timely manner
• Performs drug accountability...
Delivery - Deliverables are being completed within the project schedule timelines
• Ensure all required statutory and regulatory conditions are being met, including Competek corporate values, governance and processes
• Ensure risk assessment and response...
and commercialization strategies for our life sciences clients and ecosystem partners. You will collaborate with multidisciplinary teams and report directly to the Senior Vice President of Health Innovation, working at the intersection of strategy, innovation, and real...
and regulatory HR compliance in all areas of responsibility, including all employees and collaborators of Currie & Brown Italy.
• Evaluate and implement training programs and manage performance evaluations.
• Support continuous development and improvement within...
speed and precision to keep customer satisfaction high.
• Drive service optimization, improving response times, parts usage, and cost-efficiency.
• Track and report service KPIs to ensure continuous improvement.
Pre-Sales Support
• Collaborate with the...
reduction' compliance' and reporting obligations. - Foster knowledge sharing and collaboration with VF teams in other regions to drive best practise adoption globally to prepare for emerging regulatory compliance. - Represent the Global Sustainability team...
and Marketing colleagues of which a demonstrable affinity with seeing commercial opportunities is required. You live in Italy and are able to speak English because of the communication with the European Management team. You will report to the Lead Medical...
audits and regulatoryreporting requirements. - Identify and implement process improvements to enhance efficiency and accuracy in accounting operations. Qualifications &, Experience: - 2 to 3 years of experience in accounting' preferably with a major...
collaborate with the European CSV Coordinator to assure the GMP compliance requested for all the computerized systems in use in the Eurofins European Biopharma Product Testing.
The role will report to the EBPT CSV Coordinator and Quality/Compliance Director...
departments in preparation for the initiation of the study. Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, study procedures, and provides training on completion of the eCRF and EDC system; monitoring...