Lead Clinical Data Manager — Data Strategy & Study Leadership

Iambic; San Diego (CA); On-site; USD 152,000 - 190,000; Full time

Benefits offered by this job

Onsite gym

401K matching

Company healthcare

Uncapped vacation

Job summary

Iambic Therapeutics, a clinical-stage life-science company, is seeking a Lead Clinical Data Manager in San Diego to drive data management across one or more studies from startup through database lock and close-out.

You will lead and mentor data management teams, oversee CRO/EDC vendors, ensure CDISC standardization (CDASH/SDTM), and collaborate with cross-functional study teams to deliver high-quality, on-time data deliverables in a fast-paced environment.

Qualifications

• BA/BS in a scientific discipline, nursing, business, or information systems with 7–10+ years of clinical data management 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.

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

Clinical Data Management

EDC systems (Medidata Rave)

Vendor management

FDA regulations

ICH-GCP

HIPAA knowledge

Leadership/mentoring

Travel required

Education

BA/BS in a scientific discipline or related field

Tools

SAS

Excel

Spotfire

Python

Job description

Iambic Therapeutics, a clinical-stage life-science company, is seeking a Lead Clinical Data Manager in San Diego to drive data management across one or more studies from startup through database lock and close-out.

You will lead and mentor data management teams, oversee CRO/EDC vendors, ensure CDISC standardization (CDASH/SDTM), and collaborate with cross-functional study teams to deliver high-quality, on-time data deliverables in a fast-paced environment.