Lead Clinical Data Manager

• 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

• 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

Our mission is to make better technology for better medicines. Three values guide how we work:

• Bold. We are courageous, take thoughtful risks, and approach challenges with tenacity.
• Innovative. We are creative and find new solutions that deliver impact.
• Collaborative. We respect one another and partner with integrity.

We value the range of perspectives our people bring, and we work to build an environment where every team member can contribute and grow.

The pay range for this role is listed above. Actual pay depends on factors including experience, skills, and location. Eligible employees in the U.S. receive company-paid medical coverage, flexible spending accounts, voluntary life insurance, 401(k) matching and flexible time off. We are in a brand-new state-of-the art facility in beautiful San Diego with a community gym, dining, and easy access to great places to live and play.

Iambic Therapeutics (Nasdaq: IAM) is a technology and clinical-stage life sciences company headquartered in San Diego. By utilizing molecular superintelligence — integrating proprietary AI with automated, scalable chemistry and biology experimentation — our platform is designed to address the totality of drug discovery and development. At Iambic, we are building an engine that is designed to power the future of medicine. Learn more at iambic.ai http://iambic.ai.