Director, Clinical Data Management

Job  :
Xencor, Inc., 12770 El Camino Real, San Diego, California, United States of America Posted:
Job Family:
Director Jobs

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Salary Employment Indicator:
Hybrid Education Level: Bachelor’s Degree Introduction:
Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb® bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases.

More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit  We have an excellent opportunity for a Director, Clinical Data Management , to join our team. This position is a hybrid position with a minimum of 2 days a week onsite in our San Diego office.

Summary:

Responsible for oversight of all Data Management operational activities ensuring compliance with the corporate timeline and scope of work outsourced to CDM Contract Research Organizations.

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 Responsible for building 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 bookmarking 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 Adheres to all department and company-wide policies regarding conduct, performance and procedures Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures.

The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and…