• Acts as the primary point of contact for the local regulatory authorities, including 24/7 if legally required • Monitors and maintains awareness of safety issues and recommendations published by the local regulatory authorities, concerning the client products or products class • Monitors and maintains awareness of changes to local legislation pertaining to pharmacovigilance • Supports client audits and inspections, as required, including attendance, provision of requested documentation and completion of Corrective Actions and Preventive Actions (CAPAs), if needed • Performs local literature screening and collection of safety information • Assists on the development or the review of the local pharmacovigilance system master file (LPSMF), if required • Supports local signal detection, if applicable • Manages locally risk minimization measures, as applicable • Reports to and maintains regular communication with the EU QPPV • Supports the review of local PV agreements, if requested • Performs local PV training to eg. sales force, affiliate personnel, distributors • Provides monthly activity report on status of local PV system

• Coordinate and manage the activities of Clinical Research Associates (CRAs) across all geographic regions • Maintain close liaison with the Project Manager (PM) and other department leaders on all trial-related and service delivery matters • Support the leadership team through training, process improvements, co-monitoring visits, staff mentoring and/or other special assignments within Global Clinical Operations

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe. We are looking for a Clinical Trial Leader (CTL) to join our A-team (office-based*/remote). As a CTL at Allucent, you are providing leadership, management and oversight to the Clinical Research Associates (CRAs) and other clinical functional groups, in their day-to-day clinical trial activities on a global, multi-country, or regional basis. The CTL is responsible for coordinating and managing the planning, implementation, tracking, and ensuring the clinical deliverables as per the trial contract, budget, timelines and with quality. ResponsibilitiesAs an expert in Clinical Trial Leadership, you are: - **Coordinating and managing CRA activities **across all geographies, liaising with sponsor and Project Manager and other functional leads to ensure clinical monitoring deliverables (timeline, budget, quality, productivity) are met. - **Liaising closely with the Project Manager (PM) and other department leaders** if /when necessary, on all trial-related issues and service delivery. - **Supporting the management team **with training, process improvements, co-monitoring visits, mentoring of staff and / or any other special assignments within Global Clinical Operations.

• Represent a worldwide brand • Integrate a multicultural environment • Develop customer relationships and offer the best experience to the customer • Troubleshoot through the use of open questions, support documents, and system training • Offer recommendations to common problems or frequently asked questions