Lead Clinical Data Manager

Regulatory Jobs; United States; On-site; USD 130,000 - 190,000; Full time

Benefits offered by this job

Competitive pay

Company paid healthcare

Flexible spending accounts

Voluntary life insurance

401K matching

Uncapped vacation

Job summary

Iambic Therapeutics is seeking a Lead Clinical Data Manager to direct data management on one or more trials from start-up to lock and close-out. You will guide cross-functional teams, oversee CROs and EDC vendors, and ensure data quality and timely delivery in a fast-paced environment.

The ideal candidate has extensive CDISC experience, strong regulatory knowledge, and the ability to mentor and lead a team while driving high-quality outputs for important oncology programs.

Qualifications

• 7–10+ years in clinical data management, sponsor or CRO experience.
• Advanced knowledge of EDC systems and data structures.
• Experience overseeing CRO/EDC vendor performance and deliverables.
• Strong knowledge of FDA regulations, ICH-GCP and HIPAA.

Responsibilities

• Lead DM activities on studies from start-up through database lock.
• Oversee CRO/EDC vendor performance; ensure SOPs and timelines.
• Author and maintain DM documentation (DMP, DRP, CRF guidelines).
• Represent DM on cross-functional study teams and audits.
• Ensure CDISC CDASH/SDTM standards are applied consistently.
• Support process improvements, SOPs, and WIs.

Skills

Clinical data management

Leadership

Regulatory knowledge

CDISC standards

Cross-functional collaboration

Education

BA/BS in scientific discipline / related fields

Tools

Medidata Rave

SAS

Excel

Spotfire

Python

Job description

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

Iambic is a clinical-stage life-science and technology company developing novel medicines using its AI-driven discovery and development platform. Based in San Diego and founded in 2020, Iambic has assembled a world-class team that unites pioneering AI experts and experienced drug hunters. The Iambic platform has demonstrated delivery of new drug candidates to human clinical trials with unprecedented speed and across multiple target classes and mechanisms of action. Iambic is advancing a pipeline of potential best-in-class and first-in-class clinical assets, both internally and in partnership, to address urgent unmet patient need. Learn more about the Iambic team, platform, pipeline, and partnerships at iambic.ai.

MISSION & CORE VALUES

Our mission is to deliver better medicines through innovations in AI-based discovery technologies. The culture and work at Iambic Therapeutics are profoundly strengthened by the diversity of our people and our differences in background, culture, national origin, religion, sexual orientation, and life experiences. We are committed to building an inclusive environment where a diverse group of talented humans work together to discover therapeutics and create technologies.

PAY AND BENEFITS

• Competitive pay
• Company paid healthcare
• Flexible spending accounts
• Voluntary life insurance
• 401K matching
• Uncapped vacation

We are in a brand-new state-of-the art facility in beautiful San Diego with an onsite gym, dining, and easy access to great places to live and play.