[Hiring] Lead Clinical Data Manager @Iambic Therapeutics, Inc

Role Description

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.

Key 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.

Qualifications

• 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.

Preferred Qualifications

• 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

• Industry leading competitive pay.
• Company paid healthcare.
• Flexible spending accounts.
• Voluntary life insurance.
• 401K matching.
• Uncapped vacation.
• State-of-the-art facility in beautiful San Diego with an onsite gym and dining.
• Easy access to great places to live and play.