▷ [High Salary] Trial Transparency
6 days ago
We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service, functional service provider and consulting – allows our Excelyates to evolve through a diverse array of projects. In collaboration with preeminent experts, Excelya advances scientific, managerial, and human knowledge to improve the patient journey.
For our team members, excelling with care means benefitting from a stimulating professional environment that encourages personal, intellectual, and operational participation so that together we can be the best in our field. We commit to giving each Excelyate the means to express their natural talents, develop their full potential and invest their unique selves in our unique project.
To learn more about us, visit Clinical Trial Transparency is as a subject matter expert and advisor on transparency needs. This role will ensure that clinical study registrations and information are accurately routed, tracked, and entered in appropriate databases as per regulatory requirements and in line with policies, standards, and the law. This role will process clinical documents for anonymization and/or pseudo anonymization in support of EMA policy, EU Clinical Trial Regulation and other disclosures of clinical documents that must be redacted or otherwise anonymized to support results posting in public registries.
You will be responsible for:
Performing global clinical trial registration and result postings on clinical trial registries including ClinicalTrials.gov (CT.gov), European union Clinical Trial Register (EUCTR), registrations.
Supporting in updating and maintenance of existing protocols on CT.gov (Global protocol amendments).
Data sharing activities: including redactions of documents per EMA policy 0070, EMA policy 0043, Health Canada PRCI, third party redactions, protocol and SAP redactions for U.S. Final Rule Compliance (CT.gov).
Regulatory Intelligence: Monitoring and mapping of various country-specific registration and result posting requirements, policies, and SOPs related to disclosure domain.
You will need to have:
- 3 years working in the area of Clinical Trial Transparency- Demonstrate good communication skills and facilitation skills with the ability to work with others to achieve objectives often in challenging environments- Master’s Degree minimum- Firm understanding of Transparency and Disclosure laws, regulations and policies that will be utilized for this job role- Ability to maintain and create professional networks with stakeholders- Effective leadership skills
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Trial Transparency
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Bengaluru, India Excelya Full timeCreated in 2014, Excelya is a people-centered Contract Research Organization (CRO) that excels with care. We offer a personal and authentic experience within a young, ambitious health company on the path to becoming the clinical research leader in Europe thanks to our 800 Excelyates. Our unique one-stop provider service model – leveraging full-service,...
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