Organization Overview:
The purpose of the Associate, GSC Clinical Trial Registry Writing is to support the development and implementation of Clinical Trial Registry (CTR) systems and processes, ensuring Global transparency regulations and requirements are described and
implemented and that there are monitoring systems (and metrics) in place to ensure compliance. The CTR writer will
collaborate with cross-functional, multidisciplinary teams across multiple geographies and phases of drug development to
ensure/coordinate the accurate and timely posting of applicable clinical trial protocol information and study results.
Responsibilities:
Clinical Trial Registry and Results Planning, Development, Finalization and Document Management
Contribute to the development, maintenance, and implementation of policies and/or procedures on clinical trial registry and clinical trial results database processes and work flows. Identify prospects for process improvements.
Identify studies required for registry and results postings.
Ensure that responsible functions are aware of timelines and
deadlines.
Collaborate cross functionally with applicable team members and departments (e.g.,biostats, medical, clinical trial
management), to obtain data required for completion of registry and results entries.
Manage access rights to applicable systems as needed.
Serves as subject matter expert on CTR database requirements.
Develop and provide education and training as required to internal groups.
Define and monitor applicable metrics to support overall compliance.
Maintains and enhances knowledge of CTR regulations and guidelines.
Exhibits flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc.
Project Management / Influence / Knowledge Sharing
Supports the systems and process for CTR and works with other team members to ensure consistent practices are
monitored and employed globally.
Provides input to deliver innovat