Lead Clinical Data Manager

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🕒 Maio 22

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🟠 Sênior

📊 Cientista de Dados

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Orca

SiteLinkedInTodas as Vagas

11 - 50 funcionários

💳 Fintech

₿ Cripto

💸 Finanças

Fintech • Crypto • Finance

Orca é uma plataforma que facilita a negociação e a provisão de liquidez aproveitando a velocidade da tecnologia blockchain Solana na rede Ethereum. Permite que os usuários negociem, gerenciem portfólios e conectem suas carteiras na rede Eclipse. Projetada para fornecer uma experiência sem interrupções, combinando o ecossistema do Ethereum com as capacidades de processamento rápido do Solana, a Orca tem como alvo usuários interessados em negociações de criptomoedas e soluções de liquidez.

Descrição

• 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.

🎯 Requisitos

• 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.

🏖️ Benefícios

• 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