Lead Clinical Data Manager

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee all facets of clinical trial data management from the initiation of the study until database lock and conclusion of the study.

• Guarantees optimized data collection, processing, and accessibility across both EDC and non-EDC data sources.

• Ensures the accuracy, consistency, completeness, and compliance of all clinical databases with CDISC standards.

• Function as a vital member of the Clinical Operations team.

⛳️ Requirements

• BSc or MSc in Life Sciences, Data/Computer Science, Bioinformatics, or equivalent professional experience.

• 5-7+ years of experience in data management within the pharmaceutical or biotechnology sectors, preferably in a smaller biotech sponsor environment.

• Strong proficiency in project and program management, including effective stakeholder management.

• Familiarity with industry standards such as CDISC, SDTM, and CDASH.

• Comprehensive understanding of Data Management regulatory guidelines, including ICH, GCDMP, and 21CFR Part 11.

• Demonstrated ability to proactively identify data and system-related issues and address risks to data quality.

• Knowledge and experience in the development, validation, execution, maintenance, documentation, and archival of clinical data.

• Experience in the creation and implementation of Clinical data management standards and procedures.

• Familiarity with web-based EDC, clinical data management systems, and medical coding dictionaries like MedDRA and WHO Drug.

• Prior experience with the Zelta by Merative (formerly IBM) CDM platform is preferred.

🏝️ Benefits

• Competitive medical, dental, and vision benefits

• PTO

• 401(k) plan

• Life and accidental death and disability coverage

• Parental leave benefits

• Subsidized daily lunches and snacks at on-site locations

• Annual bonus

• Pre-IPO equity