In this role, you will provide or supervise operational and logistical support to clinical trials in Biomedical Research (BR) with a focus on high complexity and/or priority status. You will oversee junior colleagues' activities related to study operations and act as a subject matter expert and/or cross-functional liaison. **Key Responsibilities:**
Provide operational and logistical support to clinical trials in Biomedical Research (BR) with a focus on high complexity and/or priority status, ensuring compliance with Novartis processes and Good Clinical Practice (GCP). - Perform or supervise defined activities to support the Clinical Trial Team (CTT) throughout the study lifecycle, via study assignment and/or on-demand support. - Maintain, share, and actively disseminate up-to-date knowledge of ICH-GCP, external regulations, and internal procedures. Continuously strengthen expertise through training and practical application of Novartis Standard Operating Procedures (SOPs) and internal policies. - Lead finalization and management of clinical, regulatory, and study-related documents such as study protocols, patient-facing documents, etc. - Own and lead the preparation of in-scope study documents, e.g., Clinical Study Report (CSR) appendices, patient-facing documents, protocol training material, etc. - Oversee interactions and communications with relevant functions including Novartis country organizations to prepare, collect, and/or compile relevant documents, and timely follow-up on pending actions as necessary. - Manage external communication, such as newsletter development and external meeting organization. **Key Performance Indicators:**
Timely, efficient, and quality execution of trial-related activities in compliance with Novartis processes and GCP. - Proactive operational planning with effective contingency and risk mitigation plans. - High-quality contributions to study or submission documents. - Strong leadership skills to support management in team competency building, lead/contribute to local/global initiatives, and best practice sharing across programs and/or departments. **Qualifications Required:**
Minimum of 3 to 4 years' experience in clinical trial/development. - Project management experience with adept organizational skills and attention to detail. - Effective communication skills (verbal and written) and proactive communication approach. - Well-developed interpersonal skills with the ability to build rapport, manage, and coach others. - Solid presentation skills and ability to mentor/train small groups. - Ability to interact successfully with a wide range of people, including global teams, different cultures, and diverse experience backgrounds. If you are ready to contribute to a community of smart, passionate individuals dedicated to helping patients and their families, Novartis offers you the opportunity to create a brighter future together. Learn more about the benefits and rewards that Novartis provides to help you thrive both personally and professionally. Please note that Novartis is committed to fostering an outstanding, inclusive work environment with diverse teams that represent the patients and communities served. Additionally, Novartis is dedicated to working with individuals with disabilities and providing reasonable accommodations when needed. For more information about Novartis and how you can be part of this innovative and collaborative community, visit Novartis People and Culture. In this role, you will provide or supervise operational and logistical support to clinical trials in Biomedical Research (BR) with a focus on high complexity and/or priority status. You will oversee junior colleagues' activities related to study operations and act as a subject matter expert and/or cross-functional liaison. **Key Responsibilities:**
Provide operational and logistical support to clinical trials in Biomedical Research (BR) with a focus on high complexity and/or priority status, ensuring compliance with Novartis processes and Good Clinical Practice (GCP). - Perform or supervise defined activities to support the Clinical Trial Team (CTT) throughout the study lifecycle, via study assignment and/or on-demand support. - Maintain, share, and actively disseminate up-to-date knowledge of ICH-GCP, external regulations, and internal procedures. Continuously strengthen expertise through training and practical application of Novartis Standard Operating Procedures (SOPs) and internal policies. - Lead finalization and management of clinical, regulatory, and study-related documents such as study protocols, patient-facing documents, etc. - Own and lead the preparation of in-scope study documents, e.g., Clinical Study Report (CSR) appendices, patient-facing documents, protocol training material, etc. - Oversee interactions and communications with relevant functions including Novartis country organizations to prepare, collect,
