Clinical Data Privacy Specialist; Anonymization & Transparency

Position: Clinical Data Privacy Specialist (Anonymization & Transparency
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise. As the world’s largest FSP organization, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
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 Programming 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, Clinical Trials.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).
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.
Competitive base salary and performance related incentives
Health and wellbeing programs including medical, dental, and vision coverage where applicable
Retirement and pension plans
Life assurance and disability coverage
Employee assistance programs and wellbeing resources
Learning and development opportunities through structured training and career pathways
Benefits may vary depending on role and location.
Inclusion and Accessibility  ICON is an equal prospect 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  to apply.

#J-18808-Ljbffr