Study Manager

Job Purpose

The Local Study Manager (LSM) is the lead role for within-country operational feasibility, planning and delivery of Phase I-III 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, 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 the LSM 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 LSM 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 based on evolving oncology 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

Qulifications:

• Previous Clinical Operations experience with at least 6 years of in-country monitoring, study management or clinical operations management or equivalent experience; clear evidence of mastery of local study management skills with excellent understanding of the clinical research and clinical trial management- associated regulatory, processes and quality requirements.
• Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organisational objectives; able to lead at both in-country and above-country level (when acting in above-country coordinating role)
• Highly regarded for skills and expertise in the function; sought as mentor and coach by others and willingly shares knowledge and advice
• Demonstrates an excellent understanding of the clinical study , drug development , sample management and other associated process and quality requirements
• Strong project management skills (including scope, budget, timeline, and resource planning and management, and use of associated tools and support where available); comfortable projecting, managing, and reporting budget information (business and financial acumen)
• Able to lead and work within teams and networks across functional and geographical boundaries; leads by example and promotes collaboration, effective communication and leadership in others
• Able to set and manage priorities, resources, performance targets in a local / regional environment
• Effectively plans, communicates, coordinates and facilitates delivery of team objectives at both in-country and above-country level (when acting in above-country coordinating role)
• Operational expertise in risk management and contingency planning
• Deep knowledge of local regulations, IND/GCP/ICH-guidelines
• Deep knowledge of GSK SOP/POL/guidelines
• Available and willing to travel as job requires
• Acts as role model in line with GSK core values and behaviours
• Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of GSK systems/software
• Applies industry best practices to the execution of clinical studies within country to improve time and resource efficiency
• Demonstrates conceptual, analytical and strategic thinking
• Effective at problem solving and conflict resolution
• Possesses good English language written and verbal communication skills in addition to proven negotiation skills. Knowledge of local language a requirement for in-country elements of role.

我們的目標是成為全世界最具創新能力、績效最佳且最值得信賴的醫療照護公司之一。我們相信我們每個人都為 GSK 帶來獨特的東西,而且當我們將我們的知識、經驗和風格結合在一起時,就會產生令人難以置信的影響力。歡迎加入我們在 GSK 的探險行列,在這裡您將會受到啟發,為我們的病患和消費者拿出您的最佳表現。在這裡您可以盡情做您自己、體驗美妙的感受,並且不斷成長。

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