Clinical Scientifc Expert - II

Job Description

150! Clinical scientific experts, globally, are part of Global Drug Development (GDD) team, working to ensure clinical trial data and regulatory reports are of highest quality throughout the life cycle of each program, across all disease areas. Be part of a dedicated, passionate team that is diligently providing clinical and scientific inputs at study and program level, thereby supporting Novartis in reimagining medicine for patients worldwide.Your responsibilities include, but are not limited to: In collaboration with Trial Statistician, support development of Reporting and Analysis Planning (RAP) modules in line with program standards. Responsible to provide expert support in development of and implementation of relevant data capture tools in collaboration with CSD, GTL and IIS as documented in data handling plan or equivalent document (e.g. CRFs, protocol deviations, questionnaires, diaries, translations, edit checks) Responsible for performing expert review of ongoing clinical trial data as outlined in the data handling plan or equivalent, supports GTL to prepare database lock; and performing data reconciliation along the whole trial duration in collaboration with management. Collaborate with Medical Lead/BSL to identify any safety trends; and as needed, reports on trial data to safety and clinical boards (e.g. SMT, GCT, and GPT). In collaboration with Medical Lead or CSD/CSAD, responsible for final analysis and interpretation of results including the development and drafting of clinical trial reports, publications, and internal/external presentations. Provide support for biomarkers planning and or execution. Lead/ participate in global process improvement work streams or act as Subject Matter Experts for training or SOP. May support CSD in program level activities where needed including submissions. Participate in the on-boarding, mentoring and training of CSE1 and new hiresMinimum requirements Advanced (masters) degree in life sciences/healthcare (or clinically relevant degree)/ PharmD is required. PhD or MD preferable. Fluent English (oral and written) >3 years experience in Pharmaceutical industry/ clinical research organization Advanced knowledge with hands on experience in planning, executing, reporting and publishing global clinical studies in a pharmaceutical company or contract research organization. Strong interpersonal skills. Ability to work under pressure. Excellent negotiation and conflict resolution skills. Collaborates across boundaries for shared success Resolve issues with minimal/ no supervision and understands when to escalate Thorough knowledge and expertise in Good Clinical Practice, clinical trial design, statistics, regulatory processes, and clinical development process. Strong analytical / computational background Demonstrates excellent Medical / scientific writing skills. Demonstrates expert knowledge and application of statistical analysis methodology and can identify trends and analyze/ interpret/ report data effectively.Why consider Novartis 750 million. That s how many lives our products touch. And while we re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people s lives We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you re given opportunities to explore the power of digital and data. Where you re empowered to risk failure by taking smart risks, and where you re surrounded by people who share your determination to tackle the world s toughest medical challenges. We are Novartis. Join us and help us reimagine medicine. Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.,

Keyskills :
subject matter expertsmusic makingdigital conversionscientific writingclinical researchgood clinical practiceglobal drug developmentdrug developmentlife cycle