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.
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● 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.
Apply Now
Apply Now