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
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.
