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Sr. Manager, Clinical Data Management

Company: Xencor
Location: San Diego
Posted on: February 15, 2018

Job Description:

Xencor Inc. is an innovative biotechnology company located in the Los Angeles area (near Pasadena) and in San Diego. We have a very deep drug development pipeline including three programs currently in clinical testing with one more expected to start clinical testing in 2017 and have an excellent opportunity for a Sr. Manager, Clinical Data Management to join our team. We use our pioneering XmAb--technology to develop better biotherapeutics - antibodies that target new biological mechanisms and have the potential to be more potent, safer and longer lasting - with the goal of improving patient outcomes and quality of life. In addition to generating a pipeline of novel drug candidates, with ten in clinical testing by Xencor or our partners, our XmAb-- technology has enabled multiple collaborations with leading biopharmaceutical companies including Novartis, Amgen, Morphosys, Merck, CSL, Janssen(J&J), Alexion and Boehringer Ingelheim. Our employees are the most important factor in our success and we have assembled a highly talented group from diverse backgrounds and disciplines to execute our business plan and shape our future. Xencor employees value new ideas and flexibility and demand from each other scientific rigor, a passion for innovation, and a willingness to take risks. We seek a Sr. Manager, Clinical Data Management to Oversee CRO Full Service Vendor performance, and partner with cross functional study teams to ensure delivery of the Xencor portfolio. This individual achieves results through effective communication, teamwork, performance management, collaboration with other groups and a commitment to serving internal and external customers and stakeholders. This individual will ensure the highest quality data, as well as consistency across the Data Management Organization and Clinical Development Program. Job Duties include: Partnering with CDM vendors and cross functional study teams to ensure advancement of the Projects, Programs and Company portfolio. Management of vendor deliverables and relationships while representing Xencor as the point of contact for all assigned CDM activities and functions. Ensuring that data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirements Leading and/or participating in the development, review and implementation of processes, policies, SOPs and associated documents affecting CDM internal and cross-functional working groups Reviewing CDM documents within a project area to ensure consistency and quality Overview of project timelines and metrics to ensure DM deliverables are met Approval of database locks, snapshots, and all relevant CDM deliverables Contributing to the continuous improvement of DM and the wider Development organization through information sharing, training and education Development and coordination of study and project level training for relevant staff Contributing to the continuous improvement of DM and the wider Development organization through information sharing, training and education Communication and escalation of study and program level issues including processes, timelines, resourcing, performance, etc. Maintaining documentation and archival standards for Data Management deliverables including systems, databases, programs, and specifications Maintaining study-specific files to enable the reconstruction and evaluation of data management conduct in a clinical trial Requirements: Strong knowledge of drug development processes Proven success in management of CDM, projects, vendors, CRO's Excellent management, collaboration, communication and decision making skills Knowledge of FDA/ICH guidelines and industry standard practices regarding data management and GCDMP Ability to multi-task in a dynamic environment Committed to integrity, accountability, transparency, scientific rigor and drive Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice. Qualifications Bachelor's degree in computer science, mathematics, life sciences or relevant field. Pharmaceutical, Biotechnology or relevant clinical CRO experience, including 6+ years in clinical data management CDM Project Management is preferred (oversight of CRO's, electronic data vendor management, timeline management, etc.---) Previous experience with CDM systems including EDC (Medidata RAVE) and a sound understanding of CDM processes, database structure and programming concepts, and Clinical Development Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, etc.) We strive to create an environment that will challenge, motivate, and reward our employees for meeting the changing demands of creating breakthrough therapeutics. Xencor has a highly collaborative structure that integrates co-workers with different skill sets into teams for product and technology development. With an emphasis on attaining the best and most highly qualified candidates in their respective fields, we offer a competitive salary & benefits package. Please submit a cover letter & resume. For further information about Xencor, please visit our website at EOE

Keywords: Xencor, San Diego, Sr. Manager, Clinical Data Management, Executive, San Diego, California

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