Lead Clinical Data Manager

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $152k - $190k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 2%

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Iambic Therapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2019

🏥 Healthcare

💼 Consulting

🏭 Manufacturing

💰 Series B on 2024-04

Healthcare • Consulting • Manufacturing

Iambic Therapeutics is a pioneering biotechnology company that leverages advanced AI algorithms for drug discovery. Their innovative, high-throughput experimental platform aims to address unmet patient needs by optimizing molecules for various therapeutic targets. The company's AI-driven approach allows it to rapidly explore chemical spaces, revealing novel drug mechanisms and delivering high-quality leads at an accelerated pace compared to traditional methods.

📋 Description

• Serve as the primary Data Management resource on one or more clinical studies from study start-up through database lock and close-out • Coordinate Data Management activities with sponsors, CROs, and cross-functional teams • Manage database setup and design, Database UAT, query management, data cleaning, and third-party data reconciliation • Author and maintain Data Management Plans, Data Review Plans, CRF completion guidelines, data review guidelines, medical coding guidelines, and data transfer agreements • Oversee CRO and EDC vendor performance and deliverables • Assist with vendor selection, risk assessment, timeline and resource planning, and issue escalation • Represent Data Management on project teams, working groups, investigator meetings, and sponsor or health authority inspections and audits • Ensure application of data standards and CDISC conventions, including CDASH and SDTM • Contribute to process improvement initiatives, SOPs, and Work Instructions • Ensure compliance with SOPs, Work Instructions, ICH-GCP, and applicable regulations • Lead, mentor, and drive high-quality, on-time deliverables

🎯 Requirements

• BA/BS degree in a scientific discipline, nursing, business, or information systems • 7–10+ years of clinical data management experience, including sponsor and/or CRO-side experience • Advanced knowledge of EDC systems; Medidata Rave preferred • Demonstrated experience overseeing CRO and EDC vendor performance and deliverables • Strong knowledge of FDA regulations, ICH guidelines, Good Clinical Practice, and HIPAA • Oncology experience and knowledge of RECIST/RANO response criteria • Excellent communication, organizational, and cross-functional collaboration skills • Ability to travel approximately 10%, or as needed for business-critical activities • Experience supporting health authority inspections or audits preferred • Experience with Phase III pivotal studies preferred • Working knowledge of SAS or other programming/reporting tools such as Excel, Spotfire, or Python preferred

🏖️ Benefits

• Company paid healthcare • Flexible spending accounts • Voluntary life insurance • 401K matching • Uncapped vacation • Onsite gym • Dining at the facility