Job Description

Catalyst is a clinical development organization providing highly customizable clinical research solutions to the global biopharmaceutical industry through two established solutions: Catalyst Flex and Catalyst Oncology. Comprised of more than 500 members, our teams work to provide multi-therapeutic global resourcing and functional services through Catalyst Flex, and a full-service oncology CRO offering through Catalyst Oncology. we’ve built our flexible service model from more than a decade of listening to customers, devising customer-centric solutions, and helping them drive breakthrough clinical development studies leveraging our expert teams and innovative technologies.

Catalyst Flex is an established solution of Catalyst Clinical Research providing multi-therapeutic resourcing and functional services to meet the needs of clients for expert staff and functional expertise.

http://www.catalystflex.com

SR. RAVE EDC PROGRAMMER

JOB SUMMARY:

Sr EDC Programmer, as a member of Clinical Data Management, will be responsible for developing accurate clinical databases, support all functional tasks and provides technical expertise.

ROLE DESCRIPTION:

The Sr. EDC Programmer will responsible for Rave study level deliverables are completed on time, with a high degree of quality, and in accordance with client's policies. Provides technical support for the continued development and enforcement of data collection standards through updates to client’s Global Library (GLIB) specifications, and serves as an interface between Clinical Data Management, IT, Clinical Programming, and other functional groups as needed. Provides application administration and technical support as the subject matter expert on core business packages including but not limited to iMedidata, Classic Rave, Rave EDC, Business Objects and supplemental packages such as migration review, reporting tools. Works on complex study build and 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. Provides technical support for core configurations of client’s Medidata Rave URL. Responsible for client’s URL and Medidata Rave user and site administration and security, as well as study level Rave. Serves as a member on the CDM initiatives and other technical project teams. 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, BO4, Jreview, etc.), metrics and analytics. Tracks and provides archival activities. Supports with vendors holding client’s additional classic Rave URLs. When needed coordinates the activities of other Database Programmers that might assist in building studies to ensure all jobs are carried out and timelines are met. Manages the maintenance and continued development of electronic data capture (EDC) standards through updates to client's Global Library (GLIB) specifications (core and therapeutic area specific electronic Case Report Forms (eCRFs), cross-form and cross-visit edit checks, custom functions, Coding setup and EDC reporting). Performs system integration activities, application updates, and user acceptance testing. 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 feedback on standard EDC report enhancements. Supports the development of new reports, tools and dashboards for EDC related metrics and data-driven insights. Contributes in the development and/or advancement of other data capture technologies, in line with client’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. Other duties as assigned.

QUALIFICATIONS:

A minimum of a Master’s degree in computer science or a science related discipline is required. An advanced degree is preferred. A minimum 14 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. 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 3 years previous custom function programming 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.

CATALYST CLINICAL RESEARCH, LLC IS AN EQUAL OPPORTUNITY EMPLOYER. WE CELEBRATE DIVERSITY AND ARE COMMITTED TO CREATING AN INCLUSIVE ENVIRONMENT FOR ALL EMPLOYEES.

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