The Manager/Director, Clinical Data Management role oversees all Clinical Data Management operational activities ensuring compliance with the corporate timeline and scope of work outsourced to CDM Contract Research Organizations. This includes but is not limited to 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.
Job Duties include
- Provides operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards
- Responsible for building effective Data Management vendor relationships for all assigned studies. This includes being involved in RFP development, contract negotiation and selection of DM and/or technology, as needed.
- 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 / 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
- Bachelor in Life Sciences, Computer Sciences, Mathematics with 5+ years of data management experience in the pharmaceutical or biotechnology industry
- Prior clinical trial responsibility for entire data management life-cycle
- Good working knowledge of ICH, FDA, and GCP regulations and guidelines; Strong well-rounded technical skill, CDISC, STDM, MeDRA
- Understanding of data management technology, software languages and computer systems
- Demonstrated knowledge of clinical trial process and data management, clinical operations, biometrics, quality management, and systems applications to support operations.
- Skilled in multiple computer-based tools, in addition to software programs such as Word, PowerPoint, Excel, etc.
- The ability to travel as needed
- Experience in working in and contributing to cross-functional teams
- Excellent verbal/written and interpersonal skills required for working successfully in a cross-functional team environment; communicate and collaborate effectively with cross-functional teams in face-to-face conversation, by telephone, and by email
- Demonstrated ability to create strong, collaborative working relationships and encourage creative solutions by effectively working through conflicts
Xencor Inc. is an innovative biotechnology company headquartered in the Los Angeles area near Pasadena and with an office in San Diego. We recently completed a successful initial public offering (IPO). We use our pioneering XmAb® technology to develop better biotherapeutics — antibodies that target new biological mechanisms and are more potent, safer and longer lasting — to improve patient outcomes and quality of life.
In addition to generating a pipeline of novel drug candidates, our XmAb® technology is being validated through our collaborative agreements with leading biopharmaceutical companies including 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, a passion for innovation and a willingness to take risks.
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 coworkers 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 and benefits package.