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Regulatory Affairs Specialist
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Regulatory Affairs Specialist
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Clinical Affairs Specialist
2 months ago
We are seeking a highly skilled Clinical Affairs Specialist to join our team at Lifelancer. As a key member of our Medical Affairs team, you will play a critical role in ensuring the smooth management and execution of clinical trials and submissions for our development projects.
Key Responsibilities- Design and Reporting of Clinical Trials: Participate in the design and reporting of clinical trials, either directly or through Contract Research Organizations (CROs).
- Protocol Execution and Management: Execute trial protocols and be accountable for their timely execution.
- Data Management and Analysis: Collate trial data using in-house or external specimens as required, and process and accurately record biological samples and cell lines.
- Laboratory Activities: Conduct laboratory activities such as biological sample culturing, FISH setup and analysis, and troubleshooting.
- Contribution to Analytical and Practical Workload: Contribute to an assigned proportion of the analytical and practical workload within the Medical Affairs team, using in-house or external specimens as required.
- External Study Monitoring: Act as an external study monitor as directed by the Clinical Affairs Scientist, liaising and coordinating with external clinical sites to provide required clinical data.
- Background in Science: A background in a science-related subject, preferably to MSc or equivalent qualification.
- Operational Insights: Experience providing operational insights into clinical/scientific trial design, including clinical/scientific protocols, amendments, informed consent forms, study guides, and case report forms.
- Problem-Solving and Troubleshooting: An ability to use scientific knowledge to problem-solve and troubleshoot technical laboratory issues.
- GLP Environment Experience: Experience of working in a Good Laboratory Practice (GLP) environment.
- Attention to Detail and Organizational Skills: Exceptional attention to detail with very good organizational skills, with the ability to manage your daily/weekly workload and work under tight deadlines.
- Adaptability and Motivation: Adaptability and high levels of motivation, with the ability to work independently as well as part of a team.
- Process-Oriented: The ability to follow exact detailed processes carefully.
- Cytogenetic Processing Methods and FISH Analysis: Knowledge of cytogenetic processing methods and FISH analysis (desirable).
