EDC Programmer

Job Title:

EDC Programmer
Objectives:

As the EDC Engineer you will work on EDC activities and will oversee delivery of systems and documentation to support of Clinical studies. You will work with study team to develop eCRF specifications, build or oversee implementation of Case Report Forms (eCRFs) for clinical trials. Manage and oversee EDC system configuration and dictionaries. Create and own database build SOPs and processes.

You will provide consulting services to ensure implementation of technology. You will work with Data Management and standards teams to implement new processes. You will enhance existing processes for efficient and compliant way of Clinical trial build. The EDC Engineer maintains and serves as an expert for implementation of EDC best practices. The EDC Engineer would be familiar with leading EDC technologies available on the market.

You will continue developing new skills associated with EDC technologies.

Key Accountabilities:

* Create eCRF specifications, design, develop and unit test and functionally validate clinical trial setup process

* Create edit check specifications and program or modify checks at study level within EDC

* Setup different instances of study URL (eg: UAT, production, testing etc.,)

* Setup and configure user accounts for study teams

* Setup and manage blinded and unblinded study configurations

* Be the SME for all database related activities

* Setup, configure, unit test and functionally validate and integrate other modules within the EDC ecosystem such as coding, integration of IRT, safety system, local labs etc.,

* Familiar with custom functions within EDC systems

* Work closely with EDC vendors regarding any tool related issues in the system

* Ability to troubleshoot database setup as per study needs

* Prepare, test and implement post production changes as per study needs

* Archive and retire the study URL after database lock

* Partner with appropriate team members to establish technology standards and governance models

* Establish and support business process SOPs.

* Oversee system delivery life cycle in collaboration with appropriate partners including Clinical Operations, Clinical Supplies, IT, and Quality organizations

* Be a primary change agent to ensure adoption of new capabilities and business process

* Be the contact for Clinical Technology vendors to ensure established milestones are met with the highest degree of quality.

* Work with leaders to resolve issues affecting the delivery of clinical trials

* Collaborate with standards team in creating standard CRF libraries for study level consumption

* Work closely with data engineers and data management programmers at study level integration and delivery

* Lead technology vendor oversight activities.

* Be a process expert for operational and oversight models.

* Partner with appropriate team members, technology vendors, and CRO partners to avoid and resolve risks.

* Confirm archival and inspection readiness of all Clinical Technology Trial Master File (TMF) documents

* Participate in preparing function for submission readiness and may represent Clinical Information Operations (CIO) group in a formal inspection or audit.

* Track study deliverables and evaluate study metrics to mitigate risk for major data management deliverables.

* Adaptable to new ways of working using technology to accelerate clinical trial setup

* Knowledge of drug development process.

* Experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields.

* Hands-on experience study build experience in Veeva and RAVE.

* Experience programming in CQL, working with JSON format and/or C# is preferred

* Experience integrating other clinical trial modules (e.g.: lab, safety, IRT, coding etc.,) with the EDC system

* Understanding of industry standard technologies to support Clinical Development needs (e.g., CTMS, SAS, R or Python, Data Warehouses, SharePoint)