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Iambic Therapeutics, a clinical-stage biotech company developing novel medicines using an AI-driven discovery platform, is seeking a Lead Clinical Data Manager to serve as the primary Data Management resource on one or more clinical studies. This role provides project-level leadership across the full data management lifecycle, from study start-up through database lock and close-out.
You will serve as the primary point of contact for Data Management activities on assigned studies, coordinating with sponsors, CROs, and cross-functional teams. Key responsibilities include managing clinical data activities across the full study lifecycle—database setup and design, Database UAT, query management, data cleaning, and third-party data reconciliation (SAE, labs, IRT/RTSM, ePRO). You will author and maintain core Data Management study documentation including the Data Management Plan (DMP), Data Review Plan (DRP), eCRF/CRF Completion Guidelines, Data Review Guidelines, Medical Coding Guidelines, and Data Transfer Agreements.
You will provide oversight of Data Management CRO and EDC vendor performance, ensuring deliverables meet SOPs, timelines, and quality expectations. This includes assisting with vendor selection, risk assessment, timeline and resource planning, and proactive issue escalation. You will represent Data Management on project teams, internal and external working groups, investigator meetings, and during sponsor/health authority inspections and audits. You will ensure consistent application of data standards and CDISC conventions (CDASH, SDTM) across assigned studies, contribute to process improvement initiatives and SOPs, and ensure all activities comply with SOPs, Work Instructions, ICH-GCP, and applicable regulations.
The ideal candidate combines strong technical Data Management expertise with the ability to lead, mentor, and drive high-quality, on-time deliverables in a fast-paced environment.
REQUIREMENTS
Required:
- 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) and clinical data structures
- 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
Preferred:
- Experience supporting health authority inspections or audits
- Experience with Phase III pivotal studies
- Working knowledge of SAS or other programming/reporting tools (e.g., Excel, Spotfire, Python) to generate listings and review outputs
