Senior Manager, Clinical Data Management

Job not on LinkedIn

🔥 1 minute ago

🇺🇸 United States – Remote

💵 $140k - $196k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

🦅 H1B Visa Sponsor

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Generate Biomedicines

WebsiteLinkedInAll Job Openings

201 - 500 employees

Founded 2020

🧬 Biotechnology

🤖 Artificial Intelligence

💊 Pharmaceuticals

💰 $370M Series B on 2021-11

Biotechnology • Artificial Intelligence • Pharmaceuticals

Generate Biomedicines is a pioneering therapeutics company that stands at the intersection of machine learning, biological engineering, and medicine. They are leading the development of generative biology, a groundbreaking approach that uses artificial intelligence to create novel medicines with specific therapeutic functions. By studying millions of proteins, Generate Biomedicines has discovered generalizable rules by which nature encodes function, enabling them to generate medicines on demand across multiple therapeutic modalities. Their innovative platform promises to fundamentally change the way medicines are made, expanding technical possibilities and improving speed and success rates in drug discovery.

📋 Description

• Serve as the lead data manager for assigned clinical studies and programs, developing and maintaining study-specific data management strategies, timelines, and deliverables • Review and approve Data Management Plans, Data Validation Plans, edit check specifications, eCRF specifications, and database build documentation • Provide hands-on oversight of Medidata Rave EDC database builds, including eCRFs, edit checks, custom functions, workflows, and related configuration • Create, run, review, and interpret Rave reports and listings to support data review, cleaning, reconciliation, and oversight • Plan, perform, and document testing of database builds, edit checks, eCRFs, derivations, and system functionality; identify defects, assess impact, track resolution, and verify fixes through UAT • Lead data review, query management, external data reconciliation, and database lock activities, including oversight of CRO and vendor deliverables • Monitor data quality, metrics, and study timelines to identify risks early; support external data integrations, transfer specifications, reconciliation activities, and inspection readiness • Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical Monitoring, Pharmacovigilance, and external vendors throughout study conduct • Provide updates on data management activities, risks, decisions, and timelines, and escalate issues as appropriate • Review CRO financial reports, change notifications, and data management expenses for scope, budget, and timeline oversight • Contribute to continuous improvement of data management processes, standards, tools, and templates

🎯 Requirements

• Bachelor's degree in Life Sciences, Health Sciences, Computer Science, or a related discipline • At least 7+ years of clinical data management experience within the pharmaceutical, biotechnology, or CRO industry • Required hands-on experience with Medidata Rave EDC, eCOA and RTSM • Demonstrated experience creating, running, reviewing, and interpreting Medidata Rave reports and listings • Demonstrated experience testing clinical database builds, UAT scripts, edit checks, eCRFs, and database changes, including defect documentation and retesting • Solid understanding of database design, edit checks, data review, query management, external data reconciliation, and database lock processes • Strong knowledge of ICH-GCP and applicable regulatory requirements • Experience reviewing CRO study finance reports, change notifications, and data management expenses • Excellent written, verbal, and interpersonal communication skills • Strong organizational and prioritization skills, with the ability to multitask, manage competing deadlines, and maintain attention to detail

🏖️ Benefits

• Annual bonus • Equity compensation • Competitive benefits package • Equal employment opportunity