RWE Process & SOP Specialist

Our client, a leading global biopharmaceutical organization, is seeking an expert to ensure consistency and compliance in Real World Evidence (RWE) processes. The role focuses on managing the lifecycle of standard operating procedures and providing technical guidance to study teams to ensure fit-for-purpose research conduct.

• Manage the periodic review and update of RWE SOPs, forms, and templates to ensure alignment with international regulatory guidance.
• Act as a subject matter expert during the review of processes owned by other departments to ensure RWE consistency.
• Conduct gap analyses when updating procedures to facilitate appropriate risk management and implementation planning.
• Develop and deliver training materials associated with RWE processes in collaboration with internal stakeholders.
• Provide operational guidance on the implementation of processes to study teams conducting non-interventional research.
• Support the RWE study deviation process and contribute to CAPA planning for in-scope audits and quality assessments.

• You have a Master's Degree.
• You bring 5+ years of experience in a project management lead role for RWE and non-interventional studies, gained through successful end-to-end study conduct.
• You possess a strong background in best practices related to RWE study planning and execution, including primary collection and secondary data use.
• You have excellent organizational skills with a focus on attention to detail and the ability to work independently.
• You are fluent in English with excellent oral and written communication skills.

Nice to Haves

• Experience in Quality Assurance.
• Proven experience in successful cross-functional collaboration and negotiations.

• Geniet van een competitief salarispakket met extra voordelen die je talent erkennen.
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