Key Facts

Remote From:

Full time

Mid-level (2-5 years)

English

Hard Skills

Medical Privacy Digital File Management Regulatory Compliance Standard Operating Procedure Data Transformation Biostatistics Project Collaboration Medical Writing Clinical Data Analysis Project Management +2 more

Other Skills

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Microsoft Excel
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Analytical Skills
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Communication
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Time Management
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Teamwork
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Organizational Skills
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Detail Oriented

Roles & Responsibilities

Bachelor’s degree in a scientific or technical field.
Minimum 3 years of work experience in health sciences or related industries (pharmaceutical, CRO, etc.).
Working knowledge of global regulatory guidelines for clinical trial disclosure and transparency (e.g., EMA Policy 0070, Health Canada PRCI).
Strong Excel and analytical skills with working knowledge of SharePoint and/or document management systems.

Requirements:

Manage and facilitate anonymization of datasets and documents to planned timelines in accordance with SOPs and regulatory requirements.
Assess documents in-scope for public disclosure according to EMA Policy 0070 and Health Canada PRCI.
Collaborate with Biostatistics, Programming, and Medical Writing to identify and integrate required documents and datasets; develop anonymization plans addressing direct and indirect identifiers and mitigate re-identification risk per GDPR.
Ensure accurate redaction of clinical trial documents for EU CTR, ClinicalTrials.gov, and publications; perform quality checks and collaborate with Regulatory Operations to publish redacted documents in the Regulatory Document Management System.

ICON plc

Pharmaceuticals

About ICON plc

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.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

Clinical Trial Transparency Specialist

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

As a Clinical Trial Transparency Associate at ICON, you will be responsible for processing the anonymization of clinical trial documents and datasets required for public disclosure. The Anonymization Specialist will partner with internal and external collaborators on the planning, initiation, and delivery of anonymized documents and datasets in support of the EU Clinical Trial Regulation (EU CTR), ClinicalTrials.gov, and Publications and Regulatory Authority Transparency Submissions (e.g., EMA Policy 0070, Health Canada PRCI), manuscript publications, and data sharing.

What You Will Do:

· Manage and facilitate anonymization of datasets and documents against planned timelines, in accordance with Incyte SOPs and regulatory requirements.

· Assess documents in-scope for public disclosure according to EMA Policy 0070 and Health Canada PRCI.

· Work closely with Biostatistics and Programing groups and Medical Writing teams to identify and assimilate the required documents and datasets.

· Develop anonymization plans based on direct and indirect identifiers by measuring and mitigating re-identification risk according to GDPR guidance.

· Process datasets and documents and apply required transformations.

·Contribute to Anonymization Reports to support anonymization packages for policies of Health Canada and EMA.

· Ensure accurate and consistent redaction of clinical trial documents to support EU CTR, ClinicalTrials.gov, and Publications.

· Quality check of documents redacted/anonymized by other team members.

· Collaborate with Regulatory Operations to ensure the publishing of redacted documents in the Regulatory Document Management System.

· Experience with the use of Technology Tools for delivery of Anonymized Clinical Documents.

Your Profile:

· Bachelor’s degree in a scientific or technical field.

· Minimum 3 years of work experience in either the health sciences or related industries (pharmaceutical, CRO, etc.).

· Working knowledge of the global regulatory guidelines pertaining to clinical trial disclosure and transparency.

· Demonstrated experience in global clinical trial disclosure and transparency processes and systems.

· Demonstrated Excel and analytical skills, working knowledge of SharePoint and/or document management systems.

· Strong communication, organizational, time management, and project management skills.

· Knowledge of ICH-GCP, awareness of clinical publication practices and standards (ie, ICMJE).

En tant qu’Associé(e) en transparence des essais cliniques chez ICON, vous serez responsable du traitement de l’anonymisation des documents et des ensembles de données cliniques requis pour la divulgation publique. Le/la spécialiste en anonymisation collaborera avec des partenaires internes et externes pour la planification, le lancement et la livraison de documents et de données anonymisés, en conformité avec le Règlement européen sur les essais cliniques (EU CTR), ClinicalTrials.gov, ainsi que les exigences de transparence des autorités réglementaires et des publications (par exemple, EMA Policy 0070, Health Canada PRCI), les publications scientifiques et le partage de données.

Vos responsabilités :

Gérer et coordonner l’anonymisation des ensembles de données et des documents selon les délais prévus, conformément aux SOPs d’Incyte et aux exigences réglementaires.
Évaluer les documents concernés par la divulgation publique selon la politique EMA 0070 et les exigences PRCI de Santé Canada.
Collaborer étroitement avec les équipes de biostatistiques, de programmation et de rédaction médicale afin d’identifier et d’intégrer les documents et données requis.
Développer des plans d’anonymisation en tenant compte des identifiants directs et indirects, en mesurant et en réduisant les risques de ré-identification conformément aux directives du RGPD.
Traiter les ensembles de données et les documents et appliquer les transformations nécessaires.
Contribuer à la rédaction des rapports d’anonymisation pour soutenir les dossiers de soumission auprès des autorités (EMA, Santé Canada).
Assurer une caviardisation (redaction) précise et cohérente des documents d’essais cliniques pour soutenir EU CTR, ClinicalTrials.gov et les publications.
Effectuer le contrôle qualité des documents anonymisés par d’autres membres de l’équipe.
Collaborer avec les équipes des opérations réglementaires pour assurer la publication des documents caviardés dans le système de gestion documentaire réglementaire.
Utiliser des outils technologiques dédiés à la production de documents cliniques anonymisés.

Votre profil :

Diplôme de licence (Bachelor) dans un domaine scientifique ou technique.
Minimum 3 ans d’expérience professionnelle dans les sciences de la santé ou une industrie connexe (pharmaceutique, CRO, etc.).
Connaissance pratique des réglementations mondiales relatives à la divulgation et à la transparence des essais cliniques.
Expérience démontrée des processus et systèmes de transparence et de divulgation des essais cliniques au niveau global.
Compétences analytiques solides et maîtrise d’Excel, connaissance de SharePoint et/ou des systèmes de gestion documentaire.
Excellentes compétences en communication, organisation, gestion du temps et gestion de projet.
Connaissance des ICH-GCP et compréhension des pratiques et normes de publication clinique (ex. ICMJE).

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 maximize 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 site to read more about the benefits ICON offers.

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.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply