Global Clinical Lead/ctm in Rwe
hace 2 días
Global Clinical Lead/CTM in RWE (Clinical Scientist) - Sponsor-dedicated Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full‑Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives. Discover what our 29,000 employees, across 110 countries already know: WORK HERE MATTERS EVERYWHERE. ResponsibilitiesProvide observational study execution including epidemiological, non‑interventional, pragmatic and low‑interventional studies and research collaborations to ensure consistency of approach, conduct, monitoring, analysis, reporting, and oversight of core team activities within one or more asset programs in the Therapeutic Area (TA). In collaboration with cross‑functional colleagues, execute and manage projects for studies and oversee studies executed by other Clinical Scientists supporting the product. Collaborate with other Sponsor groups and oversee vendors to execute the studies. Partner with Medical Evidence Generation (MEG), Medical Affairs, Statistics, Clinical Data Sciences, Statistical Data Sciences & Analytics, and external team members, where applicable, on development of operational plans and provide input on tactical implementation of studies to support the asset strategies in line with Sponsor SOPs. As co‑lead of the Study Core Team, lead via a matrix organization to execute studies. Support complex or leading low complexity studies across various SOPs, including protocol specific training, vendor management, study level planning and oversight, data review, regulatory document, study report and publication preparation and review, overall study execution with a critical focus on consistency, quality, data integrity, safety, and alignment with company processes. Work in a global environment on studies across all regions including International, Emerging Markets and China. Represent line in program‑wide functions and governance as needed; contribute to discussions to ensure consistency across products/TA. Using knowledge of epidemiologic/observational and specific aspects of trials, provide support of operational strategic partner involvement at a program or study level; identify issues in a timely manner, lead implementation of solutions, and/or escalates as appropriate. Provide operational input on tactical implementation of studies. Qualifications BA/BS Degree in life sciences or health related field with 5+ years practical experience or MS/MBA with 3+ years, PharmD/PhD 2 years, MD/DO with 1 year. Industry experience in the Clinical Scientist role or similar capacity. Experience working on multinational teams/studies. Hands‑on experience in epidemiology study design, conduct and analysis. Experience in or leading study teams. Experience working independently and collaborating with multiple functional groups within and outside the business line. Demonstrated an ability working across multiple studies for incorporation of consistent medical/scientific concepts in multiple protocols. Strong knowledge of the clinical research process and Good Clinical Practices (GCPs), monitoring, clinical and regulatory operations. Demonstrated independent authorship of study protocols and other study documents. Working knowledge of statistics, data analysis, and data interpretation. #J-18808-Ljbffr
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Global Clinical Lead
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Buenos Aires, Argentina ACTIF A tiempo completoA global biopharmaceutical solutions organization is seeking a Global Clinical Lead/CTM in RWE. The role involves leading observational studies, collaborating with multinational teams, and ensuring consistent execution across therapeutic areas. The ideal candidate will have a strong background in epidemiology, clinical research, and project management....
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