Director, Clinical Data Management
$195,000–$240,000 year
HybridSan Diego, California, United States
Job Summary
Oversee all Data Management operational activities, ensuring compliance with corporate timelines and outsourced CRO contracts. Provide leadership on the direction, design, planning, execution, collection, and handling of clinical data to highest quality standards. Manage vendor relationships, including RFP development, contract negotiations, and selection of DM services from study start-up through close-out. Create and review study-specific documentation such as data management plans, CRF guidelines, and edit check specifications. Ensure clinical databases are designed accurately for analysis and regulatory submission by coordinating data reviews and maintaining complete supporting documentation. Manage DM-related timelines, synchronize deliverables, and implement archival standards for all systems and specifications. Train internal and external project members on CRF completion guidelines and EDC systems. Direct and coach indirect reports on performance, career development, and job expectations.
Required Qualifications
- BS in a Life Sciences, Computer Sciences or Mathematics field of study
- 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 well-rounded technical skills including CDISC, STDM, MeDRA
- Understanding of data management technology, software languages and computer systems
- Sound knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations
- Competency in multiple computer-based tools, in addition to software programs such as Word, PowerPoint, Excel, etc.
- Ability to work in and effectively contribute to cross-functional teams in face-to-face conversation, by telephone, and by email
- Excellent verbal/written and interpersonal skills
- Ability to create strong, collaborative working relationships and encourage creative solutions by effectively working through conflicts
- Ability to demonstrate competencies applicable for job based on Xencor's Leadership Competency Model
- Ability to effectively manage others through coaching and supervision, in accordance with company policies and practices
- Ensures employee performance meets the organization's expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment
- Occasional travel may be required, including travel between Xencor's Pasadena and San Diego offices
- Work for this position is generally performed at Xencor's worksite and requires full-time commitment
- minimum 2 days a week onsite hybrid position
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