Clinical Trial Transparency Specialist

📋 Description

• • The Clinical Trial Transparency (CTT) Specialist plays a pivotal role in ensuring the compliant and public disclosure of critical clinical trial information. This position is instrumental in managing the registration of clinical trial protocols, the dissemination of trial results, and the sharing of meaningful trial data with the public, thereby upholding Biogen's commitment to transparency and ethical research practices.
• • As a key contributor within the CTT function, the Specialist will focus on one or more core areas, including process optimization, technology integration, and vendor oversight. This focused approach allows for deep engagement and expertise development within specific facets of clinical trial transparency.
• • The role actively contributes to the enhancement of CTT processes, aiming to improve overall quality, efficiency, and performance. This includes meticulous tracking of compliance, accurate protocol registration, timely results disclosure, and adherence to local country disclosure requirements.
• • A significant aspect of the Specialist's responsibility involves supporting the maintenance and refinement of Standard Operating Procedures (SOPs), ensuring that all CTT activities are conducted in accordance with established best practices and regulatory guidelines. This may also extend to assisting with the development and delivery of training programs for relevant stakeholders.
• • The CTT Specialist will develop a foundational understanding of business needs and the intricate flow of information and data. This knowledge will be leveraged to contribute to the optimization of technological solutions designed to streamline CTT operations and enhance data management.
• • In the realm of vendor oversight, the Specialist will engage regularly with external suppliers. This engagement will involve a thorough review of deliverables, performance metrics, cycle times, and the proactive identification and resolution of issues, ensuring that outsourced activities meet Biogen's high standards.
• • To foster a culture of continuous improvement, the Specialist will actively identify opportunities to advance a lean and simple operating model. This collaborative effort, involving both internal team members and external suppliers, aims to create more efficient and effective transparency processes.
• • The role also involves supporting departmental projects and participating in cross-functional initiatives. This collaborative work ensures seamless alignment between Clinical Trial Transparency and other critical departments within Biogen, promoting a unified approach to information disclosure.
• • Key responsibilities include contributing to the meticulous management of disclosure activities for assigned studies. This encompasses preparing necessary inputs, diligently tracking the status of registrations and disclosures, and coordinating effectively with both internal teams and external partners.
• • The Specialist will serve as a primary point of contact for study teams, facilitating the coordination and planning of disclosure activities and acting as a liaison with the designated vendor to ensure smooth execution.
• • A core function is contributing to the ongoing enhancement of CTT processes. This includes the critical documentation of SOPs and the development of training materials, covering essential areas such as protocol registration, the disclosure of study results, and the effective dissemination of trial information to study participants and other relevant stakeholders.
• • The role requires supporting vendors to guarantee that disclosure activities for assigned studies are completed punctually and with exceptional quality, meeting all regulatory and internal requirements.
• • Support will also be provided for activities related to the creation and refinement of plain language summary documents, making complex trial information accessible to a broader audience.
• • The CTT Specialist will actively work cross-functionally on initiatives aimed at continuously improving the quality, efficiency, and overall performance of Biogen's processes, contributing to the company's operational excellence.
• • This role offers a unique opportunity to impact patient trust and scientific integrity by ensuring that clinical trial information is accessible, understandable, and compliant with global regulations. The Specialist will be at the forefront of communicating Biogen's commitment to open science and patient engagement.