Lead Clinical Data Manager

The role

The Lead Clinical Data Manager serves as the primary Data Management resource for clinical studies. This role directs activities from study start-up through database lock and close-out while providing project-level leadership.

What you will do

• Serve as the primary point of contact for Data Management activities on assigned studies
• Manage clinical data activities across the full study lifecycle
• Author and maintain core Data Management study documentation
• Provide oversight of Data Management CRO and EDC vendor performance
• Represent Data Management on project teams and working groups
• Ensure consistent application of data standards and CDISC conventions
• Contribute to Data Management process improvement initiatives, SOPs, and Work Instructions
• Ensure Data Management activities comply with SOPs, Work Instructions, ICH-GCP, and applicable regulations

Required qualifications

• BA/BS degree in a scientific discipline, nursing, business, or information systems
• 7–10+ years of clinical data management experience, including sponsor and/or CRO-side experience
• Advanced knowledge of EDC systems 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

Nice to have

• Medidata Rave 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

Benefits

• Company-paid medical coverage
• Flexible spending accounts
• Voluntary life insurance
• 401(k) matching
• Flexible time off
• Community gym
• Dining

About the company

Iambic Therapeutics is a technology and clinical-stage life sciences company headquartered in San Diego. The company utilizes molecular superintelligence to address the totality of drug discovery and development.