Director, EDC Programming

Position Overview

The Director , EDC Programming, as a member of Clinical Data Management, provides direction and management for the continued development and enforcement of data collection standards.

The Director , EDC Programming provides direction and management for the continued development and enforcement of data collection standards through updates to Nektar's Global Library (GLIB) specifications, and serves as an interface between Clinical Data Management, IT, Clinical Programming, and other functional groups as needed. Oversees and is responsible for the development and enhancements to Nektar's Medidata Rave URL core configurations, as well as Nektar's vendor URLs. Responsible for Medidata related project management, business development, and financial management. Responsible for ensuring that EDC related standards are used on all studies where possible, resulting in measurable efficiency gains. Provides direction with data standards-related projects and cross-functional data standards initiatives requiring strong attention to detail, project management, and development of standards process documents and templates. This job contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.

Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company. Participates in corporate development of methods, techniques and evaluation criteria for projects, programs, and people. Ensures budgets and schedules meet corporate requirements. Responsible for providing leadership, structure and vision for the Electronic Data Capture (EDC) business segment to meet clinical data management EDC related goals and objectives. Oversees the development and improvements to the core configurations of Nektar's Medidata Rave URL. Responsible for Nektar's URL and Medidata Rave user and site administration and security, as well as study level archival activities. Oversight and primary liaison with vendors holding Nektar's additional URLs (including, but not limited to, fostering relationships, participating in the vendors' URL risk assessments, overseeing any enhancements, monitoring performance, and troubleshooting). Primary liaison with Medidata (project management, business development, budget and contract development, and invoice approval). Manages the maintenance and continued development of electronic data capture (EDC) standards through updates to Nektar's Global Library (GLIB) specifications (core and therapeutic area specific electronic Case Report Forms (eCRFs), cross-form and cross-visit edit checks, custom functions, and EDC reporting). Supports data standards implementation by ensuring technical quality/system compliance, alignment to industry standards (e.g., CDISC) and regulatory guidance, consistency in the adoption of data standards across vendors, and provides support for study teams during data standards adoption and implementation. Coordinates with the data management team to help facilitate study EDC builds and EDC migrations in Medidata Rave. Serves as a member on the CDM Standards Committee. Facilitates discussions between Clinical Data Management, IT, Clinical Operations, Clinical Development, Clinical Programming, and EDC Programming to ensure appropriate methods are used for reporting (i.e. SAS, BO, SpotFire, etc.), metrics and analytics. Tracks and provides feedback on standard EDC report enhancements. Supports the development of new reports, tools and dashboards for EDC related metrics and data-driven insights. Partakes in the development and/or advancement of other data capture technologies, in line with Nektar's standardization goals and initiatives, such as eConsent, eMR, IRT, ePRO, etc.) Remains apprised of changing industry regulations and CDISC versions and assesses the impact on the core standards. Drives efficiencies in the investigation and implementation of new technologies around the management of data standards. Advises on EDC system improvements to increase efficiency and quality within the EDC business. Acts as intermediate between Data Management, Clinical Programming and external data providers regarding EDC data specifications and technical issues. Partners with the Data Manager and other study team members to plan for success of EDC related study deliverables. Establishes and manages EDC related operational plans, objectives, priorities and activities. Develops and refines EDC related SOPs, Work Practices, and Manuals. Assists the standards team(s) in formalizing and assessing quality of the standards governance plan. Provides specifications and creation of scripts to facilitate electronic safety reporting (setting up Rave Safety Gateway (RSG). Supports the validation of RSG. Supports regulatory submissions and/or inspections as EDC subject matter expert, when needed. Develops and maintains strong working relationships with key stakeholders. Represents Nektar's EDC business at industry conferences and events. Other duties as assigned.

A minimum of a Bachelor's degree in computer science or a science related discipline is required. An advanced degree is preferred. A minimum 13 years' related pharmaceutical/CRO experience, with demonstrated experience using Medidata Rave from a front-end data management user perspective and back-end user of Medidata Rave is required. Knowledge of data structures within clinical data management systems, especially electronic data capture systems. Must be able to demonstrate extensive experience in programming EDC databases, CRF design, query resolution, and general data validation, preferably using Medidata Rave, as an EDC programmer within Data Management or SAS programmer. Experience with a Metadata Repository or other related standards management system is a plus. Thorough knowledge of data flow and data reconciliation requirements is desired. Advanced knowledge of Data Management electronic data capture systems. Advanced experience using SAS and SQL, Crystal Reports, Business Objects and other business intelligence tools is required. A minimum of 10 years previous management experience is preferred. Must have demonstrated problem solving abilities and strong project and organizational skills. Excellent written and verbal communication skills, with a high ability to communicate standards related issues, options, and their impact to study teams and within data management are required. Demonstrated capability of working with individuals across multiple disciplines and projects. Knowledge of FDA/ICH guidelines and industry standard practices regarding the management of clinical trial data. Working knowledge of FDA Guidance Documents: Computerized Systems Used in Clinical Trials, General Principles of Software Validation. Working knowledge of 21 C.F.R. Part 11 and CDISC Standards (CDASH, SDTM, and the creation of data mapping specifications and annotated CRFs). Must be a demonstrated self-starter and team player with strong interpersonal and project management skills. Effective problem solving skills. Must have strong computer skills with a proficiency in Microsoft Project, Excel, Word and PowerPoint.

We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class. Nektar Therapeutics will consider for employment qualified applicants with criminal histories in the manner proscribed by the San Francisco Fair Chance Ordinance.