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 providing career development planning and opportunities.
- Performs other duties as required.
Education/Experience/Skills:Position requires a BS in a Life Sciences, Computer Sciences or Mathematics field of study and a 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.
Position also requires:- 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.
Expected Base Salary Range: $195,000 - $240,000
The actual salary will be based on the selected candidate's qualifications, including skills, competencies, education and experience. Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In addition, this position will be eligible for an annual bonus and equity grant. For more information, please see https://xencor.com/careers/.
