Sr. Manger Associate Director/Data Management - San Diego, CA | Biospace
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Sr. Manger Associate Director/Data Management

Xencor

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Location:
San Diego, CA
Posted Date:
10/31/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Associate, Clinical Data Management, Director, Manager,

Job Description

We seek a Sr. Manager/Associate Director Data Management to be accountable for the clinical data management strategy and function, including determination of systems and processes for clinical trials, data management resourcing plans, and development of oversight plans for outsourced activities. He/She will report to the Head of Biometrics

Core Responsibilities include:

•   Provides operational leadership to the direction, design, planning, execution, collection and handling of all clinical data to the highest quality standards

•   Coordinates and participates in the review of clinical data, including support for data review systems, development of processes and guidelines, and production of custom database reports  

•   Ensures the quality of clinical data within EDC systems at the time of database snapshots and database locks, including definition, documentation and management of all processes related to database snapshots and locks

•   Responsible for building effective DM vendor relationships. This includes being involved in RFP development, contract negotiation and selection of DM CROs and/or technology, as needed

•   Identify suitable vendor(s) for outsourcing data management activities and coordinate the review and approval of contracts[BB1]

•   Work closely with CROs to prepare and ensure proper development and execution of data management plans

•   Reviews protocols to ensure database feasibility

•   ·Ensures that eCRFs, database interfaces, programmed edit checks and external data files are designed and built in a standard, accurate, complete and consistent format to produce datasets that are conducive to analysis and possible regulatory submissions

•   Runs and reviews edit checks and resolves discrepant data

•   ·Responsible for development of CRF completion guidelines and for EDC training at Investigators' meetings and for other internal and external project members as needed

•   ·Manages coding dictionary subscriptions and integrates coding dictionaries within the EDC (e.g., MedDRA and WHODrug)

•   ·Designs and implements metrics reports summarizing data completeness (e.g. lag), monitoring progress, queries outstanding and query aging

•   Supports biological sample reconciliation and SAE reconciliation

•   Represents the data management function on study teams

•   Responsible for resourcing the data management function in support of clinical development plans

•   Defines and implements documentation and archival standards for Data Management deliverables including systems, databases, programs, and specifications, and ensures DM project documentation is in an audit-ready state

•   Maintains study-specific files to enable the reconstruction and evaluation of data management conduct in a clinical trial

•   Ensures that all clinical trials have complete and accurate supporting documentation for regulatory submission including raw datasets and bookmarked, annotated CRFs

•   Responsible for development, maintenance and governance of CDM standards (standard eCRFs, CDASH, etc.), including global, harmonized SOPs and specific quality processes and procedures for Data Management

•   ·Ensures that data management activities are conducted in accordance with GCP, GCMP, internal SOPs and all regulatory requirement

Requirements

Requirements:
•   Strong knowledge of drug development processes
•   Proven success in management of data managers and/or CROs
•   Excellent leadership, management, collaboration, communication and decision making skills
•   Knowledge of FDA/ICH guidelines and industry standard practices regarding data management
•   Working knowledge of submission requirements, e.g., Biologics License Applications (BLA) and New Drug Applications (NDA)
•   Independent, innovative, and creative thinker
•   Ability to multi-task as needed in a dynamic environment
•   Committed to the values of integrity, accountability, transparency, scientific rigor and drive


Bachelors degree in computer science, mathematics, life sciences or relevant field. Pharmaceutical or relevant clinical CRO experience, including 7+ years in clinical data management.  Previous experience with CDM systems including EDC and sound understanding of database and programming concepts, and database structure.

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.

For further information about Xencor, please visit our website at www.xencor.com