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Clinical Trial Protocol Specialist
Confidential
- Galway, Galway, Ireland
- Galway, Galway, Ireland
Über
If you would like to know a bit more about this opportunity, or are considering applying, then please read the following job information.
As Clinical Trial Protocol Specialist you will lead the design and authorship of investigational protocols across their expanding portfolio.
You will work at the intersection of clinical science, regulatory strategy, and study operations.
Responsibilities Lead Protocol Design & Authorship: Oversee Phase IIII oncology trials, including feasibility, pilot, and pivotal studies.
Translate scientific hypotheses into operationally- and submission-ready protocols, develop study synopses, and lead protocol amendments.
Endpoint & Population Selection: Select appropriate endpoints, patient populations, and clinical instruments, while developing robust scientific justifications for your selections.
Documentation Development: Draft and revise core study-specific documentation, including informed consent forms (ICFs) and patient questionnaires.
Cross-Functional Collaboration: Partner with biostatistics teams on statistical analysis plans (SAPs), and collaborate with clinical advisors to shape study design, narratives, and scientific rationale.
Regulatory Compliance: Ensure all protocols align perfectly with global regulatory guidance and applicable device/drug frameworks.
Support regulatory submissions with high-quality protocol documentation.
Research & Literature Reviews: Conduct targeted literature reviews to support study design and validate clinical assumptions.
Requirements Minimum Qualifications: Education: MD, PhD, PharmD, or equivalent advanced degree in life sciences, medicine, or a related field with a demonstrated background in oncology.
Experience: 5+ years of experience in clinical trial protocol design and authorship specifically within general oncology.
Proven Track Record: Demonstrated ability to independently author protocols for oncology trials.
Technical Knowledge: Deep proficiency with oncology-specific endpoints and CTCAE grading frameworks.
Regulatory Knowledge: Strong working knowledge of ICH guidelines and FDA regulatory expectations.
Communication: Exceptional written and verbal communication and collaboration skills.
Preferred Advantages (Nice-to-Have): Experience with medical device trials (e.g., IDE SR/NSR, De Novo, 510(k) pathways).
Experience with clinical trials focused on Quality of Life (QoL) outcomes, physical side effects, or time/financial toxicity. xyswxtq
Familiarity with Patient-Reported Outcomes (PROs).
For more information please contact Sinéad Cullen on or
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Sprachkenntnisse
- English
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