Sr CDM Technology Associate

Gilead Sciences•Foster City, CA

About The Position

Clinical Data Management (CDM) supports drug discovery, development, and marketed products across Gilead by ensuring accurate and timely acquisition, analysis and reporting of clinical data. CDM Technology provides technical services in support of CDM and cross-functional teams, including data collection standards, analysis and reporting, lab data management, Electronic Data Capture (EDC), and new technology/solution evaluation, implementation, and management activities, as needed. Given the nature of their work, CDM Technology works closely with internal CDM colleagues, as well as other partner organizations involved in drug development, including study and relevant project teams, Gilead IT, and various external vendors. You will serve as the Senior CDM Technology Associate for assigned activities of considerable complexity. You will typically oversee and guide the work of less experienced colleagues, including internal and contract personnel resources. You will typically lead special projects in support of CDM-related business activities. You may author CDM technical process/procedural documentation. You will demonstrate consistent effectiveness in managing complex projects and resolving problems in a multitude of CDM technical/solution domains, while ensuring adherence to quality standards and timelines.

Requirements

4+ years of experience and a BS/BA degree.
2+ years of experience and a MS/MA degree.
1+ years of experience and a PhD.
Excellent verbal and written communication skills, as well as interpersonal skills are required.

Responsibilities

Performs eCRF and edit check design and ad-hoc programming support for projects assigned.
Manage contract resources as a project manager / team leader in a distributed resource model.
Works collaboratively as primary or secondary programming contact with Clinical Data Associates, Statistical Programmer, Biostatistician and other Clinical, Global Drug Safety, Regulatory and Project Management staff and vendors to meet project deliverables and timelines for clinical data acquisition, quality checking and reporting according to department practices.
Ensures completeness, correctness and consistency of eCRF design, data extracts and listings, and clinical data and data structure.
Provides timely support to the study team on all programming matters according to the project plan and programming specification using internal, standards and guidelines.
Assist with the creation of listings and reports using clinical reporting and business intelligence tools and contributes to the reporting of clinical data.
Ensures secure and high integrity data transfers from vendors using data transfer standards.
Contributes to the monitoring of data quality during study conduct.
Provides information on issues along with proposed solutions, and ensuring data transfer standards are effectively communicated to vendors.
Must be able to work independently on multiple concurrent projects.
Has a working knowledge of pharmaceutical clinical development and ability to provide programming supports needs for NDA and other regulatory submissions.
Experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submission.
Has a working knowledge of relational database design, FDA regulations (particularly 21 CFR Part 11), web-based Electronic Data Capture (EDC) and clinical data management systems