Clinical Trial Transparency Associate

Clinical Trial Transparency Associate reputed company is a world-leading reputed company intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and reputed company, and we welcome you to join us on our mission to shape the future of clinical development As a Clinical Trial Transparency Associate at reputed company, you will be responsible for processing the anonymization of clinical trial documents and datasets required for public disclosure. The Anonymization Specialist will partner with reputed company 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 reputed company 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. · reputed company 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 reputed company 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 reputed company 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 reputed company 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). #LI-Remote #LI-NR1 What reputed company can offer you: Our reputed company depends on the quality of our people. That’s why we’ve made it a reputed company to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, reputed company offers a reputed company of additional benefits. Our benefits are designed to be competitive reputed company 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 reputed company 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 reputed company. Global Employee Assistance Programme, reputed company, offering 24-hour reputed company 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 reputed company offers. At reputed company, inclusion & belonging are reputed company to our culture and values. We’re dedicated to providing an inclusive and accessible environment for reputed company candidates. reputed company is committed to providing a workplace free of discrimination and harassment. reputed company reputed company applicants will receive equal consideration for employment without regard to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, 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 reputed company the essential functions of a position, please let us know or submit a request here. Interested in the role, but unsure if you meet reputed company of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly reputed company’re looking for here at reputed company whether it is for this or other roles. Are you a reputed company reputed company Employee? Please click here to apply Apply To This Job