(Senior) Study Manager (疫苗)

(Senior) Study Manager (疫苗)

GlaxoSmithKline Pte Ltd
Not Specified
Not Specified

Job Description


Job Description :

Site Name: Guangzhou Office Posted Date: May 17 2022 The Local Study Manager (LSM) 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 Study Manager (LSM) is a Local Delivery Lead who has demonstrated complete mastery of theLSMposition 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 SrLSMis 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 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 Why you Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree Experience within the Pharmaceutical Industry, clinical operations, and project management Experience in study management process of research studies Preferred Qualifications: If you have the following characteristics, it would be a plus: Experience of working on projects delivering to high quality and tight timelines. Knowledge of internal/external standards and policies Good written and verbal communication skills Ability to address obstacles and issues with a constructive solution orientated approach Advanced level of MS Office (PowerPoint, Excel, Word & Outlook) Excellent engagement skills Ability to work independently Why GSK Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. : GSK @gsk.com GSK,,GSK,[Confidential Information]

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