Sr Clinical Data Manager- hybrid (10+yr)

BS or MS in Life Sciences, Data/Computer Science, Bioinformatics OR equivalent industry experience. ● Demonstrated strong collaboration and excellent communication skills-both written and oral (proficiency in English required) ● Knowledge of CDISC data standards ● Knowledge of ICH-GCP and working in regulated environment ● Project Management skills ● Able to manage multiple requests and priorities ● Demonstrated leadership capabilities and decision-making, negotiation, motivation (self and others) and influencing ● Experience with data analytics and/or visualization tools and techniques ● Demonstrated entrepreneurial mindset and self-direction, ability to mentor others and willingness to learn new techniques ● Knowledge of biological principles, display interest and demonstrate scientific curiosity including understanding of data types and their scientific use (clinical, biomarker, WGS, RNA-seq, etc Preferred/Additional Qualifications ● Experience in leading DM study teams and maintaining oversight of all start-up, conduct and close-out activities for multiple complex studies, ensuring fit for purpose quality. ● Experience in leading the collection of clinical trial and/or Real World Data. ● Good understanding of molecule and disease area strategies, healthcare environment, as well as strong scientific and technical expertise. ● Extensive technical and or industry experience (for senior and principal roles) ● Experience in enterprise level operating systems and familiarity with databases ● Fluency in programming languages (SAS, R, Python, SQL, etc) ● Some experience with advanced analytics approaches (e.g. machine learning, AI). ● Experience with tools related to technologies required to undertake analyses on large data sources with computationally intensive steps (SQL, parallelization, Hadoop, Spark, etc) ● Experience producing interactive outputs (e.g. Shiny, Tableau). ● Contributor to open source packages, libraries or functions. ● Experience implementing reproducible research practices like version control and literate programmer. ● Experience with SDTM implementation and CDISC standards. ● Experience with standardized technologies such as MedDRA and WHODrug. ● BSN, RN, RPh, Pharm D, PA or other applicable health professional qualification preferred.