Job title: Clinical Scientific Expert II
Company: The Medicines Company
Job description: 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 dis
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.’ Position Purpose : Clinical Scientific Expert II is responsible for ensuring the collection, review/ reporting of high quality trial data, and study reporting/publishing in compliance with Novartis processes, GCP/ICH and regulatory requirements. In addition, Responsible for ensuring high quality scientific inputs to the clinical development process and support program level activities as assigned. 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 hires [#video#https://www.youtube-nocookie.com/embed/Mo1vwtVPVA0#400,300##/video#] Minimum requirements . Advanced (masters) degree in life sciences/healthcare (or clinically relevant degree)/ PharmD is required. PhD or MD preferable. With >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 Why Novartis 766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives. We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis! Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Location: Hyderabad, Telangana
Job date: Sun, 27 Feb 2022 23:46:09 GMT
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