Local Delivery Lead (LDL)
Site Name: USA - North Carolina - Durham, USA - Maryland - Rockville Posted Date: Mar 18 2021 Job Description Are you committed to lead within-country operational feasibility, planning and delivery of Phase I-IV clinical trials and epidemiological studies in a specific country or cluster of countries? Do you thrive in matrix leadership and project management of country and site-level activities including site management & monitoring activities within assigned countries? If so, this Local Delivery Lead (LDL) role could be an ideal opportunity to explore. As a Local Delivery Lead (LDL), you will serve as the operational point-of-contact between the Study Delivery Lead and in-country operational staff aligned to study. In all geographies it is recognized that the LDL 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. This role is a home based role that will provide you with the opportunity to lead key activities to progress your career. These responsibilities include some of the following: Has the skills, abilities 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). Can manage the in-country operational activities for >1 studies of significant complexity simultaneously. Can manage in-country operational study activities of complex studies in complex environments such as: 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 greater than regional average. Has responsibility for local budget spends 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; Conduct 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. 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. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: University General Science or Life Science Degree 3-4 years of previous Clinical Operations experience with at least 2-3 years of in-country monitoring or study management experience or equivalent Evidence of local study management skills, with high level of understanding of clinical research and clinical trial management, and the associated regulatory, processes and quality requirements. Strong knowledge / Experience in project management Deep knowledge of local regulations, IND/GCP/ICH-guidelines Available and willing to travel as job requires Preferred Qualifications: If you have the following characteristics, it would be a plus: Master's degree with area of Specialization in Pharmacy, Chemistry, Bio Engineer, Biology, Biomedical Sciences, Nursing 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 *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity Employer and, in the US, we adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. 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