13 beste Stellen als clinical research specialist in hessen – aktuell auf Personalsuche

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Clinical Trial Transparency Associate

ICON Plc -
Frankfurt am Main

Jetzt bewerben

Details zur Stelle

Vollzeit

Qualifikationen

Microsoft Excel
Projektmanagement
Bachelor
SharePoint
Dokumentenmanagementsysteme
Zeitmanagement

Vollständige Stellenbeschreibung

Clinical Trial Transparency 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, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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.
Experience with documents anonymization and clinical trial transparency
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).

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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:

Competitive base salary and performance related incentives
Health and wellbeing programmes including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programmes and wellbeing resources
Learning and development opportunities through structured training and career pathways

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.

Jetzt bewerben

Erweiterte Suche

clinical research specialist Jobs in hessen

Clinical Trial Transparency Associate

Site Activation Specialist - Germany

Medical / Scientific Expert (m/f/d), Clinical Development

Senior Field Clinical Specialist (m/f/d) EP - Electrophysiology

(Sr.) Site Activation Specialist (m/w/d), office-based in Frankfurt, Germany

Principal, Health Economics, Health Technology Assessment

W2 Professorship in Surgical Oncology

Site Budgeting and Contracting Specialist

W3 Professorship in Oral and Maxillofacial Surgery

Senior Scientific / Medical Expert (m/f/d), Post-Market & Life Cycle Management, R&D Clinical Development

Contract Negotiator 2 - FSP - German speaker

W2 Professorship in Medical Physics in Radiation Oncology

W2 Professorship (with W3 tenure track) in Pathomechanisms of hospital-acquired infections

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