Lead Clinical Data Manager — Drive Study Data Quality

Iambic Therapeutics, Inc.; Northern (KY); Hybrid; USD 110,000 - 150,000; Full time

Job summary

Iambic Therapeutics, Inc. seeks a Lead Clinical Data Manager to serve as the primary DM resource on multiple studies, guiding start-up to close-out, and coordinating with sponsors, CROs, and cross-functional teams.

The ideal candidate combines deep DM expertise with the ability to mentor others, maintain high-quality data, and deliver on time in a fast-paced environment. Oncology experience and CDISC standards are valued assets.

Qualifications

• BA/BS degree 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 data structures.
• Experience overseeing CRO and EDC vendor performance and deliverables.
• Strong knowledge of FDA regulations, ICH guidelines, GCP, and HIPAA.
• Oncology experience and RECIST/RANO criteria knowledge.
• 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 DM lead on assigned studies, coordinating with sponsors, CROs, and cross-functional teams.
• Manage data activities across the full lifecycle from study setup to database lock and archival.
• Author and maintain the DMP, DRP, eCRF/CRF guidelines, data transfer agreements, and related docs.
• Provide oversight of CRO/EDC vendor performance, ensuring SOPs, timelines and quality expectations.
• Represent DM on project teams, investigator meetings, and sponsor/health authority inspections.
• Ensure consistent application of CDISC CDASH/SDTM standards across studies.
• Contribute to DM process improvements, SOPs and WIs; ensure regulatory compliance.

Skills

Data management

Lead teams

Cross-functional collab

Regulatory knowledge

Travel willing

Education

BA/BS in life sciences or related field

Tools

Medidata Rave

SAS

Excel

Spotfire

Python

Job description

Iambic Therapeutics, Inc. seeks a Lead Clinical Data Manager to serve as the primary DM resource on multiple studies, guiding start-up to close-out, and coordinating with sponsors, CROs, and cross-functional teams.

The ideal candidate combines deep DM expertise with the ability to mentor others, maintain high-quality data, and deliver on time in a fast-paced environment. Oncology experience and CDISC standards are valued assets.