RWE Process

Our client, a leading biopharmaceutical organization, is looking for a specialist to ensure consistency and compliance across processes related to the conduct of RWE studies. The role focuses on managing SOPs , providing subject matter expertise, and supporting the implementation of high-quality research standards throughout the organization. Responsibilities
- Manage the periodic review and update of RWE SOPs, templates, and associated documentation to ensure compliance with international guidance.
- Act as a subject matter expert during the review of processes owned by other departments to ensure cross-functional consistency.
- Perform gap analyses on existing processes in response to new regulatory guidance or organizational changes to manage risks effectively.
- Develop and deliver training materials and process guidance for study teams conducting non-interventional research.
- Support audit preparation, study deviation processes, and the development of CAPA plans within the RWE domain.
- Maintain process trackers and contribute to new initiatives or system updates affecting study conduct. Requirements
- You possess a Master’s Degree in a relevant scientific or technical field.
- You have 8+ years of relevant experience, including 5+ years in a project management lead role for RWE or non-interventional studies.
- You bring a deep understanding of best practices related to the planning and execution of RWE studies, including primary collection and secondary data use.
- You have excellent organizational skills, strong attention to detail, and the ability to provide focused summaries from complex information.
- You are fluent in English. Nice to Haves
- Previous experience in Quality Assurance or QA.
- Experience with successful cross-functional collaboration and negotiations.