Novartis Seeks Innovative Clinical Start-Up Lead for Global Trials
Utrecht, Friday, 30 August 2024.
Novartis is recruiting a Study Start-Up Team Lead to drive operational excellence in clinical trials across Europe. The role demands expertise in optimizing start-up activities, ensuring regulatory compliance, and leading international teams. This position is pivotal in Novartis’ mission to reimagine medicine and improve lives globally.
A Strategic Role in Clinical Operations
The position of Study Start-Up Team Lead at Novartis is not just another job; it’s a strategic role that requires a deep understanding of clinical operations and trial initiation. The selected candidate will be responsible for overseeing the entire start-up process, from country allocation to site activation. This involves close collaboration with local Institutional Review Boards (IRBs) and Health Authorities to ensure that all regulatory requirements are met. The role is designed to optimize the efficiency of clinical trials, making it a vital part of Novartis’ broader mission to innovate and enhance global healthcare.
Innovative Practices and Responsibilities
The Study Start-Up Team Lead will be tasked with identifying and implementing innovative practices to streamline start-up activities. This includes data-driven decision-making in study site selection, strategic submission planning, and the collection of required documents for site activation. By optimizing these processes, the role aims to reduce study start-up cycle times and increase the efficiency of clinical trials. The candidate will also be accountable for the accuracy, quality, and timely delivery of Trial Master File (TMF) documents, ensuring inspection readiness and compliance with financial standards, ICH/GCP guidelines, and SOP requirements.
Leadership and Collaboration
Leadership is a crucial aspect of this role. The Study Start-Up Team Lead will manage and oversee a team of Start-Up Associates, ensuring they have the necessary skills to execute studies with high quality. This involves training, development, and resource management to meet productivity targets. The role also requires strong collaboration with global study teams, including the Clinical Operations Program Head and Trial Lead, to ensure that timelines and deliverables are met. Effective communication and negotiation skills are essential, as the role involves working in a global/country matrix environment.
Qualifications and Commitment to Diversity
The ideal candidate for this position will have a minimum of 5 years of experience in clinical operations and planning, along with proven leadership capabilities. A degree in a scientific or health discipline is required, and fluency in both English and the local language is essential. Novartis emphasizes the importance of diversity and inclusion, aiming to build teams that represent the patients and communities they serve. This commitment to diversity is seen as a way to enhance the quality of their work and foster a more inclusive work environment.