Sr. Local Delivery Lead

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 o 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 o 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 LDL staff in own country or in other countries/regions as required based on experience and skills in function

Why you?

Basic Qualifications:

If you have the following characteristics, it would be a plus:

• B.S. / B.A. degree or equivalent; major course of study in health-related sciences
• 6 or more years in clinical development or equivalent experience in the pharmaceutical or health-related field (Study Management , Field Monitoring or similar experience)
• Experience in project management and matrix team interactions.
• Experience in clinical trial management - associated regulatory processes

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Masters Degree in health-related sciences
• High level of understanding of clinical research management , field monitoring or similar experience gained through clinical trial management , and the associated regulatory, process and quality requirements; strong knowledge/experience in project management and matrix team interactions
• Excellent leadership skills, promoting motivation and empowerment of others in order to accomplish individual, team and organizational objectives
• Demonstrates an excellent understanding of the clinical study, drug development, sample management and other associated processes and quality requirements
• Demonstrates the discipline of risk-based planning, organizing and managing resources to ensure successful completion of specific project goals and objectives
• Exhibits strong project management skills (including scope, budget, timeline, and resource planning) and budget information (i.e., demonstrates business and financial acumen) management , and use of associated tools and support where available
• 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 environment
• Effectively plans, communicates, coordinates and facilitates delivery of team objectives
• Operational expertise in risk management and contingency planning
• Solid understanding of local and FDA regulations, GCP/ICH-guidelines
• Available and willing to travel for project related activities as required (e.g., Investigator Meetings, team meetings, etc.)
• Acts as role model in line with company core values and behaviors; willingness to mentor/train staff

Why GSK?

Our values and expectationsare 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, rigors, 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

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