Site Name: China - Beijing - ChaoYang District - Ocean International Centre - Tower A Posted Date: Sep 24 2024 The Local Associate Study Manager (LASM) is the lead role for within-country operational feasibility, planning and delivery of Phase I-IV clinical trials and epidemiological studies in a specific country or cluster of countries. They are accountable for within-country execution and delivery of assigned studies to time, budget and quality expectations as defined in the clinical development plan and study protocol as well as in local regulations, IND/GCP/ICH-guidelines, GSK Corporate, Vaccines, and local SOPS and POLs. Their scope of work includes matrix leadership and project management of country and site-level activities including site management & monitoring activities within their assigned countries. The LSM serves as the operational point-of-contact between the central Study Delivery Lead and in-country operational staff aligned to study. In all geographies it is recognized that the LSM is part of the local GSK community and collaborates closely with local medical staff (who are responsible for local medical and scientific elements of the study) as well as with Clinical Research Associates (CRA)/monitors and other in-country staff. The Local Associate Study Manager (LASM) is a Local Delivery Lead who has demonstrated complete mastery of the LASM position and possesses the expertise and seniority necessary to execute additional coordination activities at an above-country level across multiple countries and regions as required. A LASM is capable of and can be relied upon to execute all of the following: Has the skills, abilities and seniority necessary to manage the in-country operational activities associated with any type of clinical trial (prophylactic or immunotherapeutic studies as well as epidemiology and local studies) Has proven experience in managing the in-country activities associated with pivotal, Phase III and efficacy studies (the most complex studies) which are critical to company success Can manage the in-country operational activities for >1 studies of significant complexity simultaneously Can manage in-country operational activities of complex studies in complex environments Multiple local vendor involvement (insourced/outsourced local staffing, third-party vendors supporting recruitment/retention activities, visiting nurses, call centers, mobile vaccination units, etc.) Medical/clinical care setting complexity: complex patient populations in tertiary care hospital settings and academic research centers; patient populations and prescribing medical groups new to GSK Vaccines based on evolving vaccine indications; novel or unusual clinical care delivery settings Difficult environments in less developed geographies where local infrastructure is absent/not fully developed and must be facilitated and risk-managed Collaborative studies where non-GSK partners (government agencies including the military, non-governmental organizations, other manufacturers, etc.) have involvement in local study execution Number of clinical sites involved significantly greater than regional average Has responsibility for local budget spends significantly greater than regional average due to size and complexity of studies assigned Can in-country manage studies of high local subject volume (multiple thousands of subjects) requiring large numbers of clinical sites and/or high numbers of subjects per clinical site (subject density); can manage delivery of high subject volume studies requiring compressed recruitment timings (e.g. seasonal disease studies) Can develop and execute within-country operational plans to deliver non-standard projects and new indications Can serve in above-country capacity to coordinate across multiple countries within or across regions for large, multi-country studies when number of countries participating requires additional project management support Represents multiple countries in discussions with Study Delivery Leader and ensures local/central communication flow for the countries represented Through discussion with in-country LDL, understands issues in individual countries and works to ensure appropriate solutions are developed; ensures clear line-of-sight from country to study accountable Study Delivery Leader Identifies operational trends across countries within their above-country scope; liaises with other Sr LDLs performing above-country coordinating role on study to analyze trends and develop recommendations for discussion with Study Delivery Leader Supports the development and success of LDLs conducting within-country operational activities in these assigned countries by sharing knowledge, expertise and judgment in study-related issues Can preferentially be called upon to conduct activities (document review, user testing, etc.) on behalf of multiple countries/regions; qualified to represent the views of more than a single country/region in support of pan-regional efficiency Serve as coach and mentor to LSM staff in own country or in other countries/regions as required based on experience and skills in function Qualifications: Any general science degree e.g. life science, medicine, clinical research, pharmacy etc Broad experience in clinical development or equivalent experience in the pharmaceutical or health-related field. A minimum of 3-5 years clinical research experience (experience may have been in Study Management, Field Monitoring or similar experience gained at another company); Demonstrates high level of understanding of clinical research and clinical study management, and the associated regulatory, process and quality requirements; Strong knowledge/experience in project management and matrix team interactions. Good English language written and verbal communication skills. Strong negotiation skills Advanced/expert level of MS Office (PowerPoint, Excel, Word & Outlook). Why GSK? Uniting science, technology and talent to get ahead of disease together. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology). Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. 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