Lead Clinical Data Manager

Iambic Therapeutics, Inc•San Diego, CA

7d•$152,000 - $190,000•Onsite

About The Position

We are seeking a Lead Clinical Data Manager to serve as the primary Data Management resource on one or more clinical studies, directing activities from study 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 represents Data Management on cross-functional study teams. 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

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

Nice To Haves

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

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