Note: The job is a remote job and is open to candidates in USA. Iambic is a clinical-stage life-science and technology company developing novel medicines through an AI-driven discovery and development platform. The Lead Clinical Data Manager will lead data management activities across one or more clinical studies from start-up through database lock and close-out, oversee CRO and EDC vendor performance, and represent Data Management on cross-functional teams. The role also involves maintaining study documentation, ensuring data standards and regulatory compliance, and driving high-quality, timely deliverables.
Responsibilities
- Serve as the primary point of contact for Data Management activities on assigned studies, coordinating with sponsors, CROs, and cross-functional teams
- Manage clinical data activities across the full study lifecycle, from database setup and design through database lock and archival, including Database UAT, query management, and data cleaning activities, with third-party data reconciliation (e.g., SAE, labs, IRT/RTSM, ePRO)
- 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
- Provide oversight of Data Management CRO and EDC vendor performance, ensuring deliverables meet SOPs, timelines, and quality expectations; assist with vendor selection activities, risk assessment, timeline and resource planning, and proactive issue escalation as needed
- Represent Data Management on project teams, internal and external working groups, at investigator meetings, and during sponsor/health authority inspections and audits
- Ensure consistent application of data standards and CDISC conventions (CDASH, SDTM) across assigned studies
- Contribute to Data Management process improvement initiatives, Standard Operating Procedures (SOPs), and Work Instructions (WIs)
- Ensure Data Management activities comply with SOPs, Work Instructions, ICH-GCP, and applicable regulations
Skills
- BA/BS degree in a scientific discipline, nursing, business, or information systems, with 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
- 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, review outputs
Benefits
- Company-paid healthcare
- Flexible spending accounts
- Voluntary life insurance
- 401(k) matching
- Uncapped vacation
- Remote work arrangement
- Onsite gym
- Onsite dining
Company Overview
Company H1B Sponsorship