Leadership at a top-tier biopharmaceutical client, in the greater San Francisco Bay area, has exclusively engaged Junto HLS to recruit a Director – EDC Programming.
Are you a fit?
- Proven ability to directly supervise personnel
- Ability to lead strategic initiatives
- Excellent verbal and written communication skills and interpersonal skills
- Extensive understanding of the business beyond the functional area
- In-depth understanding of the overall clinical development objectives, along with the operational and system interrelationships across functions
- Proven ability to ensure EDC programming work is completed in an efficient and consistent manner
- Extensive knowledge and experience with development, validation, execution, maintenance, documentation, and archival of clinical data targeted for regulatory submissions
- Extensive knowledge of industry standards for EDC programming and pharmaceutical clinical development
- Experience with programming languages such as SAS, C#, SQL, Perl is preferred
- Extensive knowledge of relational database design, FDA regulations, web-based EDC, data exploration and reporting tools, and CDMS
Experience at Scale
- Proven ability manage a large and growing portfolio of projects across multiple Therapeutic Areas
- Oversight and management of vendors and partners.
- Direct a team of project managers and associates to manage the building of trial databases
- Lead or co-lead decisions and processes for trial database build using Electronic Data Capture (EDC) system
- Partner with Clinical Data Management in implementing and maintaining Global eCRF Libraries including eCRF layouts, database definitions and uni-variate and multi-variate edit checks
- Oversight and management of vendors and partners
- Work cross-functionally to identify and implement integrations between EDC and other systems when appropriate(e.g. systems for clinical trial management, randomization, drug safety, medical dictionary coding)
- Responsible for managing and working with a highly effective team to develop and improve processes related to electronic data capture (EDC) system configuration, global library/repository administration, study set-up, study conduct, database freeze, finalization, and archiving
- Work collaboratively across functions to meet project deliverables and timelines for clinical data acquisition, data quality checking, SAS dataset exports, and reporting
- Anticipate resource needs and ensure adequate long-term resource allocation within each therapeutic area
- Manage business relationships with EDC vendor(s) and third party outsourcing partners contracted to assist with a percentage of the EDC programming workload
- Identify, recommend, and implement new tools or system enhancements to increase group productivity
- Lead and contribute to interdepartmental initiative teams with particular focus on systems and process improvement
- Ensure EDC programming and corresponding documentation is completed in a manner that is consistent with regulations and departmental procedures
- Responsibility for oversight of EDC programming and related deliverables
- Provide primary or secondary EDC programming support for clinical trials on an ongoing basis, as well as other hands-on work such as system enhancements
- Conduct training as needed to internal and external users
- Ability to plan and manage annual budgets for database build and reporting related activities
- Greater San Francisco, CA
If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.