Senior Clinical Data Manager

October 4

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Orca

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Description

• More than one million people in the United States today are fighting blood cancer. • Orca Bio is redefining the transplant process by developing next-generation cell therapies. • This is a ~6 month contract position with potential for conversion. • The Sr. Clinical Data Manager will manage clinical trial data from start up to study close. • Responsible for EDC build, user acceptance testing, data cleaning, and reconciliation. • Ensure optimized data collection and compliance of clinical databases.

Requirements

• BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics or equivalent industry experience. • 5-7 years of data management experience in the pharmaceutical or biotechnology industries. • Strong expertise in project/program management including stakeholder management. • Knowledge of industry standards (CDISC, SDTM, CDASH). • In-depth understanding of Data Management regulatory guidelines: ICH, GCDMP, 21CFR Part 11 • Proven ability to preemptively identify data and system issues and mitigate risks to data quality. • Knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data. • Experience in development and implementation of Clinical data management standards and procedures • Experience with web-based EDC, clinical data management systems and medical coding dictionaries such as MedDRA and WHO Drug.