Director, Clinical Data Management
$195,000–$240,000 year
Hybrid · San Diego, California, United States
Job Summary
Director, Clinical Data Management lead responsible for overseeing data management operations, vendor relationships, and end-to-end data management activities from study start-up through final reporting. Oversees vendor evaluation, budget assessment, contract negotiations, and training for all CDM services; develops and reviews study-specific DM plans, CRF guidelines, coding guidelines, annotated CRFs, and edit check specifications; ensures clinical databases and external data are designed for analysis and regulatory submission; coordinates data review and preparation of datasets and tables for regulatory submission; maintains study files for data reconstruction; manages DM timelines and deliverables; implements archival standards for DM systems and documentation; provides training at investigators' meetings and to project members; leads and develops team members and ensures adherence to policies; occasional travel between Pasadena and San Diego offices. Expected Base Salary Range: $195,000 - $240,000. Includes bonus/equity and benefits; role is hybrid onsite two days per week in San Diego, CA.
Required Qualifications
- BS in Life Sciences, Computer Sciences or Mathematics
- minimum of 12 years of related experience
- at least 5 years of data management experience in the pharmaceutical or biotechnology industry
- at least 5 years of people management experience
- Prior clinical trial responsibility for the entire data management life cycle
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines
- Strong technical skills including CDISC, STDM, MeDRA
- Understanding of data management technology, software languages and computer systems
- Knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications
- Competency in multiple computer-based tools (Word, PowerPoint, Excel)
- Ability to work in cross-functional teams and communicate effectively
- Leadership competencies per Xencor Leadership Model
- Ability to manage others through coaching and supervision
- Occasional travel between Pasadena and San Diego offices
- Full-time commitment
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