Clinical Research Manager
As a key player in the success of our clinical research projects, we are seeking an experienced and skilled Clinical Research Manager to lead the planning, execution, and closure of both pre-market and post-market studies.
1. Leadership Role: Take charge of the activities of interdisciplinary team members in the planning, execution, and closure of clinical studies, ensuring seamless collaboration and effective communication.
2. Study Documentation: Develop and approve study-specific documents, tools, presentations, and processes that meet regulatory requirements and company standards.
3. Submission and Reporting: Prepare ethics submissions, protocols, patient information leaflets, informed consent forms, and case report forms, and ensure timely reporting of adverse events and study progress.
4. Database Management: Create and maintain study databases, including data entry, routine data review, and assurance of data integrity, accuracy, and protocol compliance.
5. Site Qualification and Monitoring: Take a leadership role in site qualification, study initiation, and study closure processes, and perform or delegate monitoring and site visits as required.
6. Liaison and Communication: Act as a company liaison to work with clinical sites, Contract Research Organizations (CROs), Site Management Organisations (SMOs), and other vendors/consultants, ensuring effective communication and collaboration.
7. Regulatory Compliance: Maintain familiarity with all applicable regulatory requirements and relevant clinical literature, ensuring compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, US 21CFR820, Declaration of Helsinki, Data Protection Act, and other clinical study/trial regulations.
8. Additional Responsibilities: Carry out other clinical-related duties as required, and contribute to the maintenance of Quality Management System (QMS) documentation control.