Principal Country & Site Activation Manager (Global Start Up Study Manager)

<p><span><span><b>The Country &amp; Site Activation role</b> is responsible for providing customer-focused execution of the operational strategy and management of start-up activities for studies but may also be assigned to manage whole programs of work. This includes the overall management and oversight of the following processes: country &amp; site activation and regulatory approval. This role also has responsibility for maintaining internal tracking for study site status from initial site contact through site initiation. This position will primarily work with Local Delivery Leads in the LOCs, SDLs in Rx and Vx Delivery and the Feasibility Managers and GMASE SSU Teams.</span></span></p><p><span> </span></p><p><span><span><b>Key Responsibilities</b></span></span></p><p><span><span><b>The responsibilities include but are not limited to the following:</b></span></span></p><ul><li><span><span>Lead in the development and delivery of the global plan for country and site activation</span></span></li><li><span><span>Ensures that critical study timelines related to Study Start-Up activities are achieved and that relevant cycle times, data and audit quality are met</span></span></li><li><span><span>Provides troubleshooting and problem resolution support for department to ensure productive, efficient contribution to study delivery</span></span></li><li><span><span>May act as the STOM working group lead dependent on experience</span></span></li><li><span><span>Oversees day to day delivery of all aspects of global country site activation in the projects assigned</span></span></li><li><span><span>Ensures that each project has a country and site activation plan and that country activations are planned in a single wave to maximise start up performance across all countries selected for a trial</span></span></li><li><span><span>Meets the study timelines and expectations and complies with SOPs, reporting norms, appropriate regulations, and GSK's quality standards • Input into project update and status calls, and other communications</span></span></li><li><span><span>Utilize project management skills to optimize performance and collaboration to ensure successful study outcomes</span></span></li><li><span><span>Developing appropriate early warning systems of potential obstacles to the successful completion of study start[1]up; analyses information and develops innovative solutions to challenges</span></span></li><li><span><span>Responsible for escalation of issues and reporting progress to study teams and clinical management weekly, including plans for <span>addressing/mitigating</span> risks/gaps</span></span></li><li><span><span>Maintains current knowledge of relevant country regulations, and GCP and ICH Guidelines for clinical research</span></span></li><li><span><span>Contribute to process improvement efforts both within the department and in cooperation with other departments</span></span></li><li><span><span>Transition oversight accountabilities to the SDL at the end of the start-up phase</span></span></li></ul><p><span> </span></p><p><span><span><b>Why you?</b></span></span></p><p><span><span><b>Basic Qualifications:</b></span></span></p><p><span><span><b>We are looking for professionals with these required skills to achieve our goals:</b></span></span></p><ul><li><span><span>Academic degree ( Business, Science or Math, Study Management, Clinical Operations or related discipline)</span></span></li><li><span><span>Experience with electronic document management and industry accepted standards</span></span></li><li><span><span>Significant clinical operations experience preferably across multiple TAs and phases of development in Rx and Vx</span></span></li><li><span><span>Experience of being a senior Study Start Up Lead/SSU Team Leader or have been involved with leading the delivery of clinical studies</span></span></li><li><span><span>Experience analysing data to optimize clinical trial delivery and to create various scenarios to support the operational design of a trial</span></span></li><li><span><span>Fluency in English</span></span></li></ul><p><span> </span></p><p><span><span><b>Why GSK?</b></span></span></p><p><span><span><b>At GSK we offer a wide range of additional benefits:</b></span></span></p><ul><li><span><span>Career at one of the leading global healthcare companies</span></span></li><li><span><span><b>Hybrid work ( 2/3 days per week from the office)</b></span></span></li><li><span><span>Contract of employment</span></span></li><li><span><span>Attractive reward package (annual bonus &amp; awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)</span></span></li><li><span><span>Life insurance and pension plan</span></span></li><li><span><span>Private medical package with additional preventive healthcare services for employees and their eligible counterparts.</span></span></li><li><span><span>Sports cards (Multisport)</span></span></li><li><span><span>P