Process and QD Manager

To be an integral part of the study team by providing administrative and project tracking support to the Project Manager(s) and Clinical Trial Manager(s) with emphasis on supporting inspection readiness

Process Management (BPC role):• Supports/guides BPOs in the process to develop or update process design(end-to-end Process design including set-up expectations, performElaboration Workshop and coordinate Cross-functional Alignments,Document Authoring responsibilities)• Ensures adherence to R&D documentation standards, process orientation,simplification, visualization, harmonized core language, regulatorycompliance and harmonization of processes and QDs within GDO• Develops/revises process flow diagrams using the designated system andnotation standards and supports the GDO organization as an expert forefficient process design and illustrationControlled Document & Managed Information Document Management:• Responsible for the development, review/revision, maintenance andcontinuous improvement of Quality Documents (incl. CDs and MIs) for GDO• Ensures timely review/revision of existing processes & QDs within GDO,maintaining compliance with review/renewal timelines• Owns GDO Managed Information Document ManGo Cabinet• Coordinates review and revision of documents with all appropriatestakeholders in cooperation with the process/document owner• Ensures compliance with document content and formatting standards• Represents GDO in clients R&D Development Excellence Council(DEC) and manages related activities• Ensures timely and adequate communication on behalf of the DEC to theGDO organization

• Experience in clinical research in a CRO, pharma or biotech company• Knowledge of ICH Good Clinical Practice (GCP) guidelines• Knowledge of Good Documentation Practices• Solid organizational skills, including multitasking and time-management• Good interpersonal skills• Demonstrated good written and verbal communication skills• Fluency in English (oral and written)• Experienced user of MS Office 365 toolset (Word, Excel, SharePoint,PowerPoint etc)