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Monitoring Services Oversight Manager

3 months ago

London The Westworks, United Kingdom GB16 (FCRS = GB016) Novartis Pharmaceuticals UK Ltd. Full time

Key Responsibilities:Develop country resource needs/expectations strategy and align with vendor line management (CRAs and other vendor resources). Establishes governance model Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times  Escalates non-compliance, performance issues, competency gaps and/or needs to vendors  Oversees country trial site activation, enrolment, data flow and timeline commitments are delivered per established trial objectives Oversees monitoring quality, timely data entry and issue resolution including oversight of CRA oversight visit performance Supports Clinical Development Audit and FSP vendors for site audits and inspection In collaboration with SSO Clinical Project Manager (CPM), supports recruitment strategies and site performance by ensuring high quality and compliance of monitoring activities Ensure country FSP strategy is aligned with global and hub plans Essential Requirements:Minimum 7 years’ experience in clinical research - planning/executing and/or monitoring clinical trials Experience and evidence of team leadership capabilities  Understanding of all aspects of clinical drug development with particular emphasis on monitoring and trial execution Demonstrated negotiation and conflict resolution skills  Fast change adaptability to best partner & influencing with FSP vendor on fast changing landscape Trust and rapport building is a very important skill needed Good communication skills, ability to influence others & Relationship management Excellent communicator and presenter (oral and written) Good analytical thinking