Warsaw, Masovian Voivodeship, Poland · Remote OK
Senior Clinical Scientist 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, integri…
Skills: Clinical Trial Protocol Development, Clinical Data Review, Pharmacovigilance, Regulatory Documentation, HIV Therapeutic Expertise
Warsaw, Masovian Voivodeship, Poland · Remote OK
POL-HB-SML 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, collaborati…
Skills: Clinical Trial Management, Risk-Based Monitoring, Site Monitoring, RBQM, CTMS
Warsaw, Masovian Voivodeship, Poland · Hybrid
Work Flexibility: Hybrid What you will do: The Supplier Quality Senior Engineer serves as a key role for leading Supplier Quality Controls activities and process improvement initiatives at Stryker sites. In this role, yo…
Skills: Supplier Quality Controls, Process Improvement, Quality Management Systems, ISO 13485, FDA Regulations
Warsaw, Masovian Voivodeship, Poland · Hybrid
$144k–$175k/yr
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every …
Skills: Regulatory Submissions, eCTD Publishing, Veeva RIM, Lorenz docuBridge, Submission Management
Warsaw, Masovian Voivodeship, Poland · On-site
Kim jesteśmy Diaverum to wiodący, światowy dostawca usług w dziedzinie opieki nefrologicznej, skupiony na poprawie jakości życia pacjentów z chorobami nerek. Dysponujemy ponad 30-letnim doświadczeniem w leczeniu chorób n…
Skills: Nephrology, Internal Medicine, Patient Care, Treatment Planning, Medical Documentation
Warsaw, Masovian Voivodeship, Poland · Remote OK
Job Overview: Serve as a member of the project team with primary responsibility for clinical data review, query generation / resolution and reconciliation to support the delivery of clinical data according to client qual…
Skills: Clinical Data Management, Data Review, Query Generation, Electronic Data Capture, Data Management Plan
Warsaw, Masovian Voivodeship, Poland · On-site
We are looking for a AI/ML Research Scientist to join our team. In this role, you will drive innovative research at the intersection of artificial intelligence and semiconductor design, developing novel machine learning …
Skills: Python, C++, PyTorch, Transformers, Graph Neural Networks
Warsaw, Masovian Voivodeship, Poland · On-site
Medison is a global pharmaceutical company providing access to highly innovative therapies to patients in international markets, including EPM. Medison is the first to create an international commercialization platform f…
Skills: Market Research, Business Development, Commercial Assessment, Primary Market Research, Secondary Market Research
Warsaw, Masovian Voivodeship, Poland · On-site
Company Description Milestone One is a Site Enabling Services organization with global headquarters in Zug, Switzerland. We understand what clinical study sites need and our overall mission is to support sites in stronge…
Skills: ICH-GCP, Clinical Trial Coordination, Patient Enrollment Tracking, EDC Systems, Regulatory Documentation
Warsaw, Masovian Voivodeship, Poland · Remote OK
Company Description We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a netw…
Skills: Sterilization Processes, Medical Device Compliance, MDR, IVDR, ISO 13485
Warsaw, Masovian Voivodeship, Poland · On-site
$280k–$287k/yr
Minimum qualifications: Bachelor’s degree or equivalent practical experience. 2 years of experience with software development in one or more programming languages (e.g., Go), or 1 year of experience with an advanced degr…
Skills: Go, ML Infrastructure, Model Deployment, Model Evaluation, Optimization
Warsaw, Masovian Voivodeship, Poland · Hybrid
Director, Data & Information Marketplace Introduction to role: Are you ready to build an enterprise-wide data and information marketplace that turns trusted data into a competitive advantage for patients and the business…
Skills: Data Marketplace Strategy, Data Governance, Product Management, User Experience Design, Information Lifecycle Management
Warsaw, Masovian Voivodeship, Poland · Hybrid
Hi, we're glad you're here! We are hiring to our Aviva Services Excellence Centre! Take a look at our job description - maybe it suits you or one of your friends? What will you be doing? Supporting the cyclical reserving…
Skills: R Programming, MS Excel, VBA, Quantitative Analysis, Actuarial Modeling
Warsaw, Masovian Voivodeship, Poland · Hybrid
Regulatory Affairs ManagerDepartment: Regulatory Affairs ManagementLocation: PL, Warsaw Model: hybrid 3+2 Description: The Regulatory Affairs Manager (RAM) is a regulatory specialist with project management capabilities …
Skills: Regulatory Affairs, Project Management, Submission Strategy, Stakeholder Management, Dossier Preparation
Warsaw, Masovian Voivodeship, Poland · Hybrid
SEB is a leading Northern European financial services group with a strong focus on risk identification, measurement, monitoring, and governance. As banking becomes increasingly data‑driven and model‑intensive, model vali…
Skills: Quantitative Analysis, Model Validation, R, Python, SQL
Warsaw, Masovian Voivodeship, Poland · On-site
Key Account Partner, Trixeo (woj. Wielkopolskie i Lubuskie) Teren pracy: województwa wielkopolskie (Czarnków, Trzcianka, Chodzież, Oborniki, Międzychód, Nowy Tomyśl, Grodzisk, Kościan, Wolsztyn) i lubuskie (Świebodzin) K…
Skills: Sales Strategy, Relationship Management, Medical Promotion, Analytical Skills, MS Office
Warsaw, Masovian Voivodeship, Poland · Hybrid
$320k–$534k/yr
You will lead site engagement activities for respiratory clinical studies based in Poland. You will build and maintain strong relationships with clinical sites and local clinical teams to ensure smooth study delivery. Yo…
Skills: Clinical Site Engagement, Good Clinical Practice (GCP), Site Start-up, Relationship Management, Clinical Operations
Warsaw, Masovian Voivodeship, Poland · Remote OK
Senior Clinical Research Associate 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…
Skills: Clinical Trial Monitoring, Good Clinical Practice (GCP), Site Management, Regulatory Compliance, Data Integrity
Warsaw, Masovian Voivodeship, Poland · Hybrid
Location: Warsaw, Poland Hybrid model of work: 3 days in office, 2 remote per week The Operational Data Strategy (ODS) function provides strategic oversight for how clinical operations data is collected, organized, valid…
Skills: Python, Machine Learning, SQL, NoSQL, Power BI
Warsaw, Masovian Voivodeship, Poland · Hybrid
$209k–$254k/yr
Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every …
Skills: Biostatistics, Clinical Trial Design, SAS, R, Python
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Design and conduct clinical studies to evaluate the safety and efficacy of innovative treatments, focusing on protocol development and regulatory documentation. Perform high-quality clinical data review and provide insights to improve data integrity and subject safety throughout the study lifecycle.
Requires an advanced degree in life sciences or healthcare and at least 5 years of experience as a Clinical Scientist. Expertise in the HIV therapeutic area is required, preferably within Phase 1-3 clinical research and vaccine development.
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.
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.
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
#LI- remote
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
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.
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
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
Offices: ICON plc, South County Business Park, Leopardstown, Dublin, D18 X5R3, IE · 123 Smith Street, Farmingdale, New York NY 11735, US · Block 2, Hamilton House, National Technology Park, Limerick, V94 TRW8, IE · 100 Longwater Avenue, Green Park, 3rd Floor, North and South Wings, Reading, England RG2 6GP, GB · 1 Almondview Office Park, West Lothian, Livingston, EH54 6SF, GB
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