Lead Clinical Data Manager

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🕒 May 22

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

📊 Data Scientist

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Orca

WebsiteLinkedInAll Job Openings

11 - 50 employees

💳 Fintech

₿ Crypto

💸 Finance

Fintech • Crypto • Finance

Orca is a platform that facilitates trading and liquidity provision by leveraging the speed of Solana blockchain technology on the Ethereum network. It allows users to trade, manage portfolios, and connect their wallets on the Eclipse network. Designed to provide a seamless experience by combining Ethereum's ecosystem with Solana's rapid processing capabilities, Orca targets users interested in cryptocurrency trading and liquidity solutions.

📋 Description

• Responsible for all aspects of clinical trial data management from study start up through database lock and study close. • Ensures optimized data collection, flow and access across EDC and non-EDC data sources. • Ensures accuracy, consistency, completeness and CDISC compliance of all clinical databases. • Operate as a key member of the Clinical Operations team.

🎯 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, preferably in smaller biotech sponsor environment. • 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. • Prior experience with Zelta by Merative (formerly IBM) CDM platform 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