Lead Clinical Data Manager: Drive Data Excellence

Iambic Therapeutics, Inc; San Diego (CA); On-site; USD 130,000 - 180,000; Full time

Benefits offered by this job

Company-paid healthcare

401K matching

Uncapped vacation

Job summary

Iambic Therapeutics in San Diego is seeking a Lead Clinical Data Manager to serve as the primary Data Management resource on one or more studies, directing activities from start-up through database lock and close-out.

This role provides project-level leadership across the full data management lifecycle, oversees CRO and EDC vendor performance, and mentors teams to deliver high-quality, on-time deliverables in a fast-paced, regulated environment.

Qualifications

• BA/BS degree in a scientific discipline, nursing, business, or information systems; 7–10+ years of clinical data management experience
• Advanced knowledge of EDC systems (Medidata Rave preferred) and clinical data structures
• Experience overseeing CRO and EDC vendor performance and deliverables
• Strong knowledge of FDA regulations, ICH guidelines, GCP, and HIPAA
• Oncology experience and RECIST/RANO knowledge
• Excellent communication, organizational and cross-functional collaboration skills
• Ability to travel ~10% as needed

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 through database lock and archival
• Author and maintain core Data Management study documentation (DMP, DRP, eCRF/CRF guidelines, Data Review Guidelines)
• Oversee Data Management CRO and EDC vendor performance; assist with vendor selection, risk assessment, and timeline/resource planning
• Represent Data Management on project teams and inspections/audits
• Ensure adherence to CDISC standards (CDASH, SDTM) across studies
• Contribute to SOPs and Work Instructions; ensure regulatory compliance

Skills

Clinical data management

Lead cross-functional teams

Communication

Project leadership

Education

BA/BS degree in a scientific discipline

Tools

Medidata Rave

SAS

Excel

Spotfire

Python

Job description

Iambic Therapeutics in San Diego is seeking a Lead Clinical Data Manager to serve as the primary Data Management resource on one or more studies, directing activities from start-up through database lock and close-out.

This role provides project-level leadership across the full data management lifecycle, oversees CRO and EDC vendor performance, and mentors teams to deliver high-quality, on-time deliverables in a fast-paced, regulated environment.