Associate Director Study Delivery Lead

Site Name: Italy - Siena Posted Date: Dec 15 2022 Associate Director Study Delivery Lead Job Purpose: The Associate Director Study Delivery Lead is the Project Manager of a study. As such, the Associate Director SDL is accountable to ensure that the study team is planning and executing the study according to time, budget and quality and as defined in the Development Plans (Clinical, Epidemiology, Global and Local studies), in the study management plan, in the study protocol, and in adherence with ICH-GCP guidelines, GSK Vaccines control documents and within regulatory requirements. Key Responsibilities: The Associate Director SDL is ensuring the translation of scientific objectives in the Study Management Plan. By using integrated processes, tools and measures the Associate Director SDL ensures the study oversight, delivery of the study on time, according budget and with quality, using a risk based approach methodology: The Associate Director SDL develops a study management plan including forecast, detailed schedule, budget and Quality Management Plan Ensures a study-level risk assessment is performed, ensures that identified risks are appropriately mitigated . Develops and maintains Study Risks Management Plan Ensures development and management of Study Quality Management Plan and conduct related quality assessment, endorses proposal for site assessments/audits, analyze and follow up assessment reports Prepares monitoring and communication plans (including definition of study essential data for adaptive monitoring) Ensures issue escalation and management up to resolution; communicates progress and escalates issues to the Project Delivery Lead when appropriate In partnership with the Clinical Research Development Lead (CRDL), Epidemiologist , Country Medical Directors (for local studies), co-ordinates all members of the study network to ensure the appropriate experts (both central and local, operational and medical/scientific) are involved at appropriate stages and outputs are delivered on time Leads a multifunctional team to ensure study Oversight, study delivery and takes operational decisions at study level (will refer to Project Delivery Lead as needed). Each Study Core Team member is responsible to have the oversight of the activities pertaining to his department as well as oversight related to vendors Ensures appropriate study oversight including study kick off meeting(s), regular TC with LOC/CRO, review protocol deviations, escalation process and ensure appropriate follow-up actions are taken Develops and maintains, with the Study Core team, the study dashboard including key risk indicators (KRIs), key performance indicators (KPIs) and other study related reports / tools Ensures functional strategy and plans are developed, maintained and executed including clinical supplies, sample management, data management, document management and quality . Each study core team member keeps his own accountability to ensure planning and execution of his departmental plans Requirements: University Scientific Degree (General Science or Life/Health related Science Degree) Master, Post graduate degree in a life science field desirable (Pharmacy, Chemistry, Bio Engineer, Biology, Biomedical Sciences, Project Management) Why you? The candidate has > 4 years of significant experience in managing complex clinical research studies, clinical operations or equivalent. Has a very good understanding of the clinical research and clinical trial management, associated regulatory, processes and quality requirements. 2 years of experience in regional clinical study leadership desirable. Strong skills and experience in project management and tools, in depth knowledge of GCPs and ICH guidelines / stakeholder management Excellent communication and presentation skills Solid experience working in teams with a broad range of cultures, including team leadership Agile project management experience preferable or preferred Why GSK? GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organization where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together. Inclusion & Diversity at GSK: Inclusion and diversity at GSK are key for our success. Here, you will thrive through bringing your unique experiences to both our company and the recruitment process. We want you to be you, feel good and keep growing your career. GSK is an Equal Opportunity and Affirmative Action Employer. Applicants will travel through a transparent recruitment journey that adheres to all required employment standards and regulations. Beyond this, we commit to our values of integrity and respect towards every applicant. We want to hear from you and support with any adjustments that you may require during the recruitment process. Please get in touch with our Recruitment Team (contact email) to further discuss this today. We will request equal opportunities information from you and whilst disclosure is optional, we encourage you to be open, enabling us to monitor the inclusivity of our recruitment practices for the benefit of everyone. Your data will remain confidential, is never shared with our Hiring Managers and never affects the status of your application. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years. Our success absolutely depends on our people. 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