Job Description
Role Description The Scientific Officer is responsible for overseeing research activity and ensuring the scientific integrity of the research design of clinical trials at Atlantia Clinical Trials Ltd. The science team provides core specialist support for research methodology, ethics, and maintenance of an assessment tool library. The team offers timely and proportionate advice and expertise to sponsors on all aspects of clinical research design and regulatory compliance relevant to their research trial. The Science Team works collaboratively with other departments that support the research project cycle from research idea through to project delivery and impact. The Atlantia Science Team is looking for a Scientific Officer to oversee relevant scientific decisions and ensure compliance with research best practices. The role involves developing and promoting tools and training to enhance staff awareness and compliance with research integrity, ethics governance, and regulatory compliance. Key Responsibilities Management of the Science Department staff (research managers, regulatory manager, statisticians & start-up coordinators) and processes, ensuring projects adhere to established timelines and budgets. Contribute to the development of clinical protocols, reports, and publications in line with scientific and clinical best practices. Ensure that all research activities comply with ethical standards, national laws and regulations, including the preparation and submission of documents to The Health Products Regulatory Authority (HPRA), Institutional Review Boards (IRB), and Ethics Committees (EC). Prepare and submit documentation for ethics, IRB, and regulatory applications, and store according to Atlantia’s policies and regulatory requirements. Write and review Clinical Study Reports (CSRs), publications, and other scientific communications to ensure they accurately reflect the data and conclusions of the study. Liaise with the assigned statistician during the development of statistical analysis plans and assist in the selection of statistical tests. Screen relevant literature and information from scientific societies meetings and conferences, developing summaries of key messages for use within the Company. Establish and maintain professional relationships with external experts and academic centres, participating in scientific congresses and coordinating advisory boards. Communicate scientific findings to stakeholders, including sponsors, regulatory bodies, and the scientific community. Maintain in-depth knowledge for assigned product(s)/therapeutic area(s) through attendance at key meetings, congresses, and seminars, and by regular self-study of literature. Have good knowledge and experience of clinical research operations, including interpretation and implementation of ICH guidelines/FDA regulations. Develop and update relevant education materials and resources related to regular research procedures. Identify opportunities for training and contribute scientifically to train other departments; develop and update relevant training materials. Develop and maintain a library of scientific resources relevant to commonly used processes at Atlantia. Assist the Quality and Operations Team in identifying potential quality issues and implementing actions to resolve them. Review and approve scientific content in promotional material, ensuring compliance with Atlantia’s internal policies and guidelines. Represent Atlantia at relevant trade shows and conferences to help build the brand and showcase capabilities. Qualifications PhD in a relevant field plus relevant experience in clinical research required; experience in pre-clinical research is a plus. Research experience across nutrition and clinical research. Relevant experience working in clinical trials or in another regulatory affairs-related position. Proven ability to gather information and apply analytical skills to reach decisions on technical issues. Demonstrated understanding of the research of Exempt Medicinal Products on the Irish market. Involvement in international scientific communities relevant to Atlantia’s research areas (APC, ISAPP, PRI, etc.). Excellent communication skills, including strong interpersonal skills, leadership, and presentation skills, proven by a strong publication and conference presentation record. Job Types: Full-time, Permanent Benefits: Bike to work scheme Company events Company pension Flexitime On-site parking Sick pay Wellness program Schedule: 8 hour shift Monday to Friday No weekends Application question(s): Do you have a proven track record of report/publication writing and presentation skills? Education: PhD (required) Experience: Nutrition and clinical research: 5 years (required) Work Location: In person Application deadline: 23/09/2024 #J-18808-Ljbffr