Lead Clinical Data Manager

Highlights

• Lead data management across full study lifecycle from setup to database lock.
• Serve as primary Data Management contact for sponsors, CROs and study teams.
• Help advance novel AI-discovered medicines for urgent unmet patient need.

What they offer

• Company-paid healthcare
• Flexible spending accounts
• Voluntary life insurance
• 401(k) matching
• Uncapped vacation
• Onsite gym and dining in San Diego facility

Ideal candidate

Experienced clinical data leader who thrives owning studies end-to-end and mentoring teams. Organized, collaborative communicator passionate about data quality and advancing oncology medicines in a fast-paced environment.

Requirements

• BA/BS in scientific discipline, nursing, business, or information systems with 7-10+ years 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% as needed
• Experience supporting health authority inspections or audits
• Experience with Phase III pivotal studies
• Working knowledge of SAS or other reporting tools to generate listings and review outputs