Senior Clinical Scientist
ICON
Spain, Madrid
Full-Time
$1,235
RemoteSenior
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
As a Senior Clinical Scientist at ICON, you will design and conduct clinical studies that evaluate the safety and efficacy of innovative treatments.
What You Will Do:
Contribute to the development and creation of clinical trial protocols following high scientific and clinical standards and applicable regulations.
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 (as applicable)
Support pharmacovigilance activities (e.g. contributing to creation and review of aggregate reports, patient narratives and attendance of pharmacovigilance monitoring meetings)
Support regulatory activities (preparation of meetings with regulatory agencies).
Produce training materials, share best practices and provide training to the broader clinical trial teams.
Support preparation and (if applicable) participate in study level meetings (i.e. - Investigator Meetings, Data Monitoring meetings, and others).
Support and guide 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). Includes support for Case Report Form (CRF) development, and implementation of data capture tools.
Deep expertise to perform in depth and high-quality clinical data review, to identify clinical data insights through ongoing patient level review and trends analysis to support Interim Analysis, Database and Post Lock activities and resolution of scientific & medical issues throughout the study lifecycle.
Work to improve the quality of reviews and insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
Provide insights to and facilitate data review process improvements by identification of redundant reports, implementation of innovative data analysis processes and tools, and their continuous improvement.
For all these tasks, work in close collaboration and alignment with clinical development lead. Ensure all questions / issues requiring medical oversight are brought to the attention of the clinical development lead.
Qualifications
Advanced degree in life sciences/ healthcare or clinically relevant degree.
Minimum 5+ years' experience as a Clinical Scientist
HIV therapeutic area expertise required, preferably in Phase 1 – 3 clinical research environment; ideally paired with expertise in Vaccine Development or Infectious Diseases
Preferred knowledge of set-up, organization and execution of global clinical studies in a pharmaceutical company or contract research organization (CRO) environment
Sound knowledge of principles of clinical data collection and reporting with a demonstrated ability to use typical systems and tools (e.g., EDC systems, Excel, etc.) for data collection, analysis and reporting.
Demonstrated knowledge to drive continuous improvement of processes, systems and tools.
Experience to work in a matrix, with high level of ability to informally influence and collaborate without authority
Home Based
No travel
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Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.
Are you a current ICON Employee? Please click here to apply