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Xencor Square4 days ago

Director, Clinical Data Management

$195,000–$240,000 year

Hybrid · San Diego, California, United States

Type
Full Time
Level
Senior Level
Education
Bachelors Degree
Company size
Unknown

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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$195k – $240k / yr

Director, Clinical Data Management · Xencor Square

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