Lead Clinical Data Manager

JOB SUMMARY

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

Required

• 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

• 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

ABOUT IAMBIC THERAPEUTICS

MISSION & CORE VALUES

PAY AND BENEFITS