Lead Clinical Data Manager

Openkrill; United States; Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

Company paid healthcare

401K matching

Uncapped vacation

Onsite gym

Dining facilities

Job summary

Iambic Therapeutics is seeking a Lead Clinical Data Manager to direct Data Management activities from study start-up through database lock and close-out. This role leads the DM lifecycle, mentors staff, and ensures high-quality, on-time deliverables in a fast-paced environment.

The ideal candidate has strong technical DM expertise, knowledge of EDC systems (Medidata Rave), CDISC standards, and experience overseeing CRO/EDC vendors. Oncology experience is a plus, with around 10% travel required.

Qualifications

• BA/BS in scientific discipline, nursing, business, or information systems with 7–10+ years of clinical data management experience.
• Advanced knowledge of EDC (Medidata Rave preferred) and clinical data structures.
• Experience overseeing CRO/EDC vendor performance and deliverables.
• Strong knowledge of FDA regulations, ICH guidelines, GCP, and HIPAA.
• Oncology experience and RECIST/RANO criteria knowledge.
• Excellent communication, organization and cross-functional collaboration.
• Travel approximately 10% for business-critical activities.

Responsibilities

• Serve as the primary Data Management contact for assigned studies and coordinate with sponsors, CROs, and cross-functional teams.
• Oversee full study data lifecycle from database setup/design to lock/archival, including UAT, queries, data cleaning, and third-party reconciliation.
• Author and maintain DMP, DRP, eCRF/CRF guidelines, Data Review Guidelines, Coding Guidelines, and Data Transfer Agreements.
• Provide oversight of DM CRO/EDC vendor performance; assist with vendor selection, risk assessment, timelines, and escalation.
• Represent DM on project teams, investigator meetings, and sponsor/health authority inspections/audits.
• Ensure consistent application of CDISC (CDASH, SDTM) standards across studies.
• Contribute to DM process improvements, SOPs, and Work Instructions.
• Ensure DM activities comply with SOPs, WIs, ICH-GCP, and applicable regulations.

Skills

EDC systems

Medidata Rave

Data management

Vendor management

Communication

Travel

Education

BA/BS degree

Tools

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 http://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

We offer industry leading competitive pay, company paid healthcare, flexible spending accounts, voluntary life insurance, 401K matching, and uncapped vacation to our team. 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.