Director, Clinical Data Management

Primary Responsibilities

• Provides operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards
• Oversees vendor and technology evaluation, qualification and selection, budget assessment and contract negotiations, training and oversight for all CDM services from study start-up through study close-out and final reporting
• Buils effective Data Management vendor relationships for all assigned studies, including involvement in RFP development, contract negotiation and selection of DM and/or technology
• Creates and/or reviews study specific Data Management and database documentation which may include data management plans, CRF completion guidelines, coding guidelines, annotated CRFs, and edit check specifications
• Ensures clinical databases and external data files are designed in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and regulatory submission by working with lead CRO data manager or equivalent
• Coordinates and participates in the review of clinical data, analysis tables/listings/figures and patient profiles for data consistency and accuracy
• Ensures clinical data within the clinical DB is of a quality to lock as appropriate for clinical review and statistical analysis
• Ensures that all clinical trials have complete and accurate data and supporting documentation for regulatory submission and data analysis including raw datasets and bookmarked annotated CRFs
• Maintains study-specific files to enable the reconstruction and evaluation of data management conduct in a clinical trial
• Manages DM-related timelines; coordinates and synchronizes deliverables and milestones with overall timelines
• Implements documentation and archival standards of Data Management deliverables including DM systems, databases, programs, and specifications
• Provides training of the CRF completion guidelines, EDC system at Investigators' meeting and to internal and external project members as needed

Qualifications

• BS in a Life Sciences, Computer Sciences or Mathematics field of study
• Minimum of 12 years of related experience, with at least 5 years of data management experience in the pharmaceutical or biotechnology industry, and at least 5 years of people management experience
• Prior clinical trial responsibility for the entire data management life cycle is also required
• 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