What are the responsibilities and job description for the Senior Clinical Scientist - Oncology position at Pharmaceutical Research Associates, Inc?
Overview
As a Senior Clinical Scientist you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Senior Clinical Scientist will support late phase development in oncology area, this role is dedicated to a global biotech company
Responsibilities
Responsibilities
- Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations. Also contribute to the identification, formulation and implementation of amendments to the clinical protocol, in close collaboration with clinical lead.
- Contribute to the creation of study-level documents, including preparation of clinical sections of key regulatory documents, such as Investigator’s Brochures, briefing books, safety updates and submission dossiers. Contribute to the review and writing of clinical trial documents for CTR activities, and publications (if applicable).
- Support pharmacovigilance activities (e.g. contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings)
- Support regulatory activities, like preparation of meetings with regulatory agencies
- Supports and guides the development of data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites). This could also include support for Case Report Form (CRF) development, and implementation of data capture tools.
- Perform high quality clinical data review and identify clinical data insights through ongoing patient level review and trends analysis, thereby supporting for example Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle
#LI-REMOTE
#LI-NR1
Qualifications
You are:
- Advanced degree in life sciences/ healthcare or clinically relevant degree.
- 8 years for Sr. Clinical Scientist; 5 years for Clinical Scientist
- Experience as a clinical scientist support late phase development in the areas of breast and lung cancer.
- Knowledgable in all aspects of drug development including medical data review.
- Sound knowledge of principles of clinical data collection and reporting; demonstrated ability to use systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting. Ideally first experiences in how to improve and accelerate processes, systems and tools and drive continuous improvement.
What ICON can offer you:Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.Our benefits examples include:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.