The Senior Local Delivery Lead (Sr LDL) is a Local Delivery Lead who has demonstrated complete mastery of the LDL 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 Sr LDL 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:
1.Multiple local vendor involvement (insourced/outsourced local staffing, third-party vendors supporting recruitment/retention activities, visiting nurses, call centers, mobile vaccination units, etc.)
2.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
3.Difficult environments in less developed geographies where local infrastructure is absent/not fully developed and must be facilitated and risk-managed
4.Collaborative studies where non-GSK partners (government agencies including the military, non-governmental organizations, other manufacturers, etc.) have involvement in local study execution
5.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 :
1.Represents multiple countries in discussions with Study Delivery Leader and ensures local/central communication flow for the countries represented
2.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
3.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
4.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 LDL staff in own country or in other countries/regions as required based on experience and skills in function
Why You?Basic qualifications:
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.
Strong knowledge / Experience in project management
Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational 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 Vaccines core values and behaviors
Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of GSK Vaccines 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.
In September 2015, GSK established a new global centre for vaccines research and development (R&D) in Rockville, Maryland. The site is one of three global vaccines R&D centres for GSK, complementing the company's existing global R&D centres in Rixensart, Belgium and in Siena, Italy.
The new US vaccines R&D centre will expand GSK's efforts to discover and develop novel vaccines across a range of pressing public health threats, including those relevant to the US. It will consolidate vaccines R&D activities currently conducted at other GSK sites including in Philadelphia, PA and Cambridge, MA, into one centralised location. Key late stage development programmes, as well as vaccine discovery and new platform technology development will be led from Rockville.
Our Vaccines business has a broad portfolio and innovative pipeline of vaccines to protect people of all ages. We deliver over two million vaccine doses per day to people living in over 160 countries. The vaccines in our portfolio have been helping to protect people from serious disease for well over 100 years, with our Marietta (US) site dedicated to smallpox vaccine production since 1882. Today, our vaccines continue to tackle some of the world's most devastating diseases, including pneumococcal disease, meningitis, hepatitis, rotavirus, whooping cough and influenza. Our Vaccines business has a portfolio of more than 40 vaccines for every stage of life, helping to protect people against 22 diseases. We have a pipeline of 14 candidate vaccines in development. One third of our vaccines in development target diseases particularly prevalent in the developing world, including all three WHO infectious disease priorities: HIV, malaria and TB. Our other vaccines in development include vaccines for the treatment of COPD and prevention of Respiratory Syncytial Virus (RSV). In October 2017, our shingles vaccine, Shingrix, received regulatory approval in Canada and the US.
GSK has a 150-year legacy of helping to transform the health, lives and futures of millions of people around the world. We're a science-led healthcare company with more than 100,000 people working in 115 countries. Each year we produce around 4 billion packs of medicine, nearly 900 million doses of vaccine and more than 18 billion packs of consumer healthcare products. Our focus of helping people do more, feel better and live longer is at the center of all that we aim to do.
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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