Job ID: REQ-10020271
Date: Aug 29, 2024
Location: Ireland
SummaryWhen we put our heads together, we can do brilliant work. And when we do brilliant work, we can achieve remarkable things for patients as we positively transform healthcare. We are looking for a Senior Study Leader to join our global team. The Senior Study Leader is responsible for the execution and delivery of the Global Clinical Operations (GCO) supported clinical studies per the Operational Execution Plan (OEP) and clinical study protocol. You will lead the cross-functional clinical trial team (CTT), guiding planning and management of the assigned clinical study/studies end-to-end to achieve Global Program Team (GPT), Global Clinical Team (GCT), and GCO objectives. The Senior Study Lead will oversee budget and people allocation within assigned study/studies, promote operational excellence through process improvement and knowledge sharing across studies, and foster an empowered, psychologically safe organization that can navigate a matrix environment. This role can be based in our Dublin office in a hybrid model.
About the RoleYour responsibilities will include: Leading the clinical trial team delivery of multiple medium to complex global studies and promoting learning, sharing, consistent performance, and operational excellence through an agile mindset.Acting as the CTT product owner with duties and responsibilities per the agile ways of working.Guiding planning and decision making at the study level and delivering assigned clinical study/studies per the Operational Execution Plan (OEP) and clinical study protocol.Fostering an agile culture within assigned studies to achieve sprint goals and cycles, maximizing collaboration and minimizing dependencies.Promoting operational excellence in the development of global clinical study protocol(s) in collaboration with regulatory writing and clinical development.Creating effective CTT dynamics and achieving performance, prioritization, and communication in collaboration with CTT sub-team leaders.Proactive risk management and inspection readiness.Fostering a close working relationship with SSO Clinical Project Managers (CPMs), VPG Vendor Program Managers (VPMs), and CDO Trial Data Scientist (TDS).Overseeing study recruitment and activating mitigation strategies in collaboration with the SSO Clinical Project Managers (CPMs).Ensuring proper handling of all study close-out activities including site close-out, final drug accountability, and audit readiness of Trial Master File documentation.Partnering and collaborating with PSP/Clinical Operations Program Head (COPH) to deliver clinical studies in alignment with program strategy.Achieving excellence in study operations and management through process improvement in collaboration with the Study Leadership Community Lead/Host and GCO Process, Training, and Compliance (PTC).Minimum RequirementsQualifications: Bachelor's degree in life sciences/healthcare (or clinically relevant degree) is required. Advanced degree is preferred.= 4 years of recent involvement in clinical research or drug development in an academic or industry environment spanning clinical activities in Phases I through IV.= 3 years of recent contribution to and accomplishment in all aspects of conducting clinical studies in a global/matrix environment.Experience in managing people globally in a complex matrix environment preferred.Experience in developing effective working relationships with internal and external stakeholders.Excellent communicator and presenter (oral and written); ability to communicate at all levels.Strong negotiation and conflict resolution skills.Strong project management skills and demonstrated ability to meet timelines.Superior strategic thinking with strong analytical and problem-solving skills.Knowledge of appropriate therapeutic area preferred.Why Novartis? Our purpose is to reimagine medicine to improve and extend people's lives. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us!
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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