Lead Clinical Data Manager
Clinical-stage life-science and technology company that develops medicines using an AI-driven discovery and development platform.
Funding history
About Iambic Therapeutics
Iambic Therapeutics combines proprietary AI technologies, including Enchant and NeuralPLexer, with automated chemistry and biology experimentation to discover and develop small-molecule medicines. Its current pipeline includes clinical and preclinical oncology candidates.
Skills
Candidate Availability
Required and preferred rules are kept separate and reflect the wording in the original posting.
About the Role
You will lead data management for assigned clinical studies from start-up through database lock and close-out. You will oversee CRO and EDC vendors, manage data quality and reconciliation activities, create study documentation, apply CDISC standards, support audits, and ensure regulatory compliance.
Requirements
- BA/BS degree in a scientific discipline, nursing, business, or information systems
- 7–10+ years of clinical data management experience
- Sponsor-side and/or CRO-side experience
- Knowledge of EDC systems and clinical data structures
- Experience overseeing CRO and EDC vendor performance
- Knowledge of FDA regulations, ICH guidelines, Good Clinical Practice, and HIPAA
- Oncology experience
- Knowledge of RECIST/RANO response criteria
- Ability to travel approximately 10%
Responsibilities
- Lead data management activities for assigned clinical studies
- Manage data activities from database setup through archival
- Author and maintain data management study documentation
- Oversee CRO and EDC vendor performance
- Represent data management on project teams, working groups, inspections, and audits
- Apply CDISC conventions across studies
- Contribute to process improvements, SOPs, and work instructions
- Ensure compliance with SOPs, ICH-GCP, and applicable regulations
Benefits
- Company-paid healthcare
- Flexible spending accounts
- Voluntary life insurance
- 401K matching
- Uncapped vacation
- Onsite gym
- Dining