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Clinical study manager

Cork
beBeeResearch
Clinical study manager
Posted: 12 July
Offer description

Job Overview:


We are seeking a highly skilled Clinical Research Associate to join our team. In this role, you will be responsible for designing, planning, implementing, and managing the overall conduct of clinical research projects.

Your primary objective will be to ensure compliance with protocols and clinical objectives as well as applicable SOPs and regulations. You will work closely with interdisciplinary teams to assist in the planning, execution, and closure of pre-market and post-market clinical studies.

Key Responsibilities:
1. Assisting team members in the planning, executing, and closing of clinical studies. 2. Developing and approving study-specific documents, tools, presentations, and processes. 3. Preparing ethics submissions and study-specific documents such as protocols, patient information leaflets, informed consent forms, and case report forms. 4. Maintaining Trial Master Files and Investigator Site Files for multiple studies. 5. Preparing and presenting at Investigator meetings. 6. Participating in the site qualification, study initiation, and study closure process. 7. Assisting with the management of medical device tracking and accountability. 8. Creating and maintaining study databases, including data entry, routinely reviewing data/CRFs to ensure data integrity, accuracy, and protocol compliance. 9. Tracking and reporting progress of studies to internal stakeholders including patient screening, enrolment, data collection, adverse event documentation, and reporting. 10. Developing study reports and providing clinical reports for regulatory submissions. 11. Performing monitoring and site visits, including preparation of site visit, data query, adverse event, and study deviation reports. 12. Acting as a liaison to work with clinical sites, Contract Research Organizations (CROs), Site Management Organizations (SMOs), and other vendors/consultants. 13. Maintaining familiarity with all applicable regulatory requirements and relevant clinical literature. 14. Maintaining compliance with ISO 13485, ISO 14155, ICH GCP, EU MDR, US 21CFR820, Declaration of Helsinki, Data Protection Act, and any other clinical study/trial regulations. 15. Carrying out other clinical-related duties as required. 16. Activities related to Quality Management System documentation control as required.

Requirements:
1. Bachelor's degree in Science or related disciplines with a minimum of 4 years of experience in the medical device industry. 2. Experience in pre-market and post-market clinical studies of medical devices essential. 3. Clinical certifications desirable. 4. Thorough understanding and knowledge of ISO 13485, ISO 14155, ICH GCP, US 21CFR820, and EU MDR. 5. Proven track record with the ability to successfully manage projects to deadlines. 6. Strong ability to manage critical projects as part of an interdisciplinary team. 7. Excellent problem-solving and communication skills. 8. Self-motivated, highly organized, and detail-oriented. 9. Excellent oral and written communication skills. 10. Ability to work as part of a cross-functional team. 11. Thrive in a fast-paced environment.

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