Clinical Transparency Associate Role
We are seeking a detail-oriented and organized Clinical Transparency Associate to join our team. As a key member of our clinical research team, you will play a crucial role in ensuring the transparency and integrity of our clinical trials.
About the Job:
This is an exciting opportunity for a highly motivated individual to contribute to the success of our clinical trial operations. You will be responsible for coordinating various aspects of transparency activities, including collecting and managing content for redaction/anonymization and tracking and publishing data transparency deliverables.
Your primary focus will be on ensuring that all documents meet quality standards and regulatory requirements, while also providing support to our clinical document specialists and scientific writers.
Responsibilities:
* Transparency Activity Coordination: Coordinate operational aspects of transparency activities, including collecting content for redaction/anonymization and managing the release of anonymized content.
* Data Management: Track and publish data transparency deliverables using appropriate systems and tools.
* Regulatory Compliance: Apply data transparency standards, requirements, processes, and policies to comply with health agency regulations.
* Document Management: Manage documents within submission repositories, including indexing and archiving in accordance with quality standards.
Requirements:
* Redaction Experience: 1-3 years of experience in redaction and personal information protection in scientific fields, preferably with a background in pharma, CRO, or other related areas.
* Clinical Document Specialist: Experience as a clinical document specialist or similar role, preferably with knowledge of electronic document management systems and Adobe Acrobat.
* Talent Development: Basic understanding of clinical trial or submission document disclosure requirements, health authority regulations, and guidelines.
About Our Culture:
We prioritize diversity, high performance, and talent development. Our benefits include competitive salary, health insurance, retirement plans, global Employee Assistance Programme, life assurance, and flexible benefits like childcare vouchers, gym discounts, and travel passes.
At our organization, inclusion and belonging are core to our culture. We strive to create an inclusive, discrimination-free workplace where everyone can thrive.