Clinical Trial Transparency Associate
Required skills
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)
Responsibilities
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
