Study Delivery Lead

Site Name: USA - Pennsylvania - Philadelphia, Canada - Ontario - Mississauga Posted Date: Oct 21 2021 Are you energized by the opportunity to partner with key leaders in global medical science to enhance global operational support? If so, this Study Delivery Lead could be an exciting opportunity to explore. As a Study Delivery Lead, you will provide operational support to the Global Medical Sciences team within the business and provide flexible operational support within various functions across Global Medical Sciences. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… The SDL 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 The SDL prepares monitoring and communication plans (including definition of study essential data for adaptive monitoring) The SDL ensures issue escalation and management up to resolution. The SDL communicates progress and escalates issues to the Project Delivery Lead when appropriate The SDL defines resource requirements and ensure appropriate resourcing (including outsourcing) o The SDL tracks delivery to time, cost and quality, ensures maintenance of standard tools such as iPlan, eTrack and SAP. The SDL sets up the Study Dashboard to facilitate the integrated study oversight. Each Study Core Team member has his own accountability to ensure control and monitoring of his departmental plans. The SDL is accountable for the study budget The SDL, 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 The SDL 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 The SDL 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 The SDL 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 The SDL communicates progress to Project Delivery Lead and study team Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in General Science or Life/Health related Science Degree 6+ years of experience in managing clinical research studies, clinical operations or equivalent . Experience in the clinical research and clinical trial management, associated regulatory, processes and quality requirements. Preferred Qualifications: If you have the following characteristics, it would be a plus: Advanced Degree in Life Sciences 2+ years of experience in regional clinical study leadership (field experience) Strong skills and experience in project management and tools In depth knowledge of GCPs and ICH guidelines Excellent communication and presentation skills Solid experience working in teams with a broad range of cultures, including team leadership 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 *This is a job description to aide in the job posting, but does not include all job evaluation details. 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). 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