Clinical Data Manager – Full Time Contractor

🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $95 - $115 / hour

⏳ Contract/Temporary

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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BBOT

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

BBOT is a biotechnology company developing targeted therapies for cancers driven by RAS signaling and PI3Kα. The company focuses on rational drug design to inhibit the active ON state of RAS and to selectively block RAS-driven PI3K activation, aiming at multiple KRAS mutants and novel approaches to maximize target inhibition. BBOT translates decades of RAS biology research into therapeutic candidates intended to improve outcomes for patients with RAS- and PI3Kα-driven tumors.

📋 Description

• Develop and maintain Data Management Plans (DMPs), data validation specifications, data review plans, and related study documentation • Review eCRFs, edit checks, database specifications, and EDC functionality to ensure fit-for-purpose design and alignment with study requirements • Conduct ongoing data review, identify discrepancies and trends, and manage data queries through resolution to ensure timely and complete data cleaning • Reconcile EDC data with external data sources including central laboratory, imaging, ECG, PK/PD, eCOA, IRT/RTSM, and safety data • Support SAE reconciliation, user acceptance testing (UAT), interim analyses, and database lock activities, ensuring all activities meet timelines and quality standards • Monitor data transfers and oversee CRO and vendor deliverables, proactively identifying and resolving data quality, timeline, and operational risks • Ensure compliance with applicable regulations, SOPs, study procedures, and CDISC/CDASH standards throughout all data management activities • Partner with Clinical Operations, Biostatistics, Statistical Programming, Medical, Safety, Regulatory, CROs, and vendors to support seamless cross-functional data execution • Contribute to improving data review, cleaning, reconciliation, and database lock processes; support SOP development and process documentation as needed

🎯 Requirements

• Bachelor’s degree in Life Sciences, Computer Science, Data Management, or a related field • 5+ years of clinical data management experience in biotechnology or pharmaceutical development, including experience supporting studies through database lock • Proficiency with Medidata Rave, Veeva Vault CDMS, or comparable EDC systems • Experience with external data reconciliation, data transfers, edit check specifications, validation specifications, and database documentation • Solid knowledge of clinical data standards and regulations, including CDISC/CDASH, ICH-GCP, and risk-based data management principles • Experience managing CRO and technology vendors in a data management capacity • Strong analytical, organizational, communication, and problem-solving skills • Ability to work independently and manage competing priorities in a fast-paced biotech environment • Preferred: Oncology, early-phase, or first-in-human clinical studies • Preferred: Experience with IRT/RTSM, central laboratory, imaging, PK/PD, eCOA, ECG, or safety data streams • Preferred: Familiarity with data review tools, dashboards, automated checks, or AI-enabled data review platforms • Preferred: Experience building and improving data management processes in a small-to-mid-size biotech environment

🏖️ Benefits

• Initial contract engagement with potential to convert to a full-time employee (FTE) role based on performance and organizational need • Estimated weekly utilization of 40 hours a week