Clinical Technical Specialist

Job Requirements

Company Overview

ConcertAI's mission is to accelerate insights, advance research, and improve patient outcomes in oncology and across life sciences. ConcertAI's leading real-world evidence, AI technology and software-as-a-service solutions support healthcare decision-making across clinical research & development through commercialization. Top biopharma sponsors, clinical research organizations, healthcare providers and institutions rely on ConcertAI's evidence-generation and digital transformation capabilities to advance precision medicine and medical innovation.

ConcertAI has emerged as one of the fastest growing AI health tech companies backed by industry-leading private equity companies: SymphonyAI Group, Declaration Partners, Maverick Ventures, and AllianceBernstein PCI.

Role Summary

We are seeking a talented and motivated Clinical Technical Specialist with experience in Software as a Service (SaaS) to join our dynamic Digital Trial Solutions engineering team. In this role, you'll be part of a small team working on the creation and validation of electronic case report form (eCRF) specifications, design clinical trial setups, and implement comprehensive edit checks for trial-level data quality. You'll be participate in User Acceptance Testing (UAT) scripts and managing various study instances, ensuring a seamless experience for study teams. You'll oversee EDC database activities and integrate diverse modules within the EDC ecosystem. Your role demands a discerning understanding of custom functions within EDC systems and the ability to troubleshoot database configurations as per study requirements. This role embraces adaptability to new technologies, leveraging them to accelerate clinical trial setup for optimal results.

Responsibilities

• Create electronic case report form (eCRF) specifications, design, develop and validate clinical trial setup process

• Create data dictionary, edit check specifications and setup edit checks at trial level

• Implement UAT scripts to test the setup of the clinical study

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

• Setup and manage blinded and unblinded study configurations

• Setup, configure, validate and integrate other modules within the EDC ecosystem such as

• Query management, reporter, coding, integration of IRT, safety system, local labs etc.,

• Understanding of when custom functions are required within EDC systems

• Ability to troubleshoot database setup as per study needs

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

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

• 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

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

• Work closely with DTS engineering and data management programmers on study level

• integrations and deliveries

• 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

Requirements

• Bachelor's degree in Computer Science, Information Technology, or related field

• Knowledge of drug development process.

• 3+ years experience in Data Management, Programming, Clinical IT, or other Clinical Research related fields.

• Hands-on experience with Veeva / Medidata Rave is mandatory

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

• Experience integrating other clinical trial modules (eg: 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)

• Experience with healthcare EHR data sets like Cerner, Epic is an added advantage.

• Proven experience in software support, ideally within a SaaS environment

• Knowledge of different databases like, AWS RedSift, PostgresSQL, GraphQL etc

• Drive optimization, testing and tooling to improve quality of solutions

• Experience with NoSQL databases like MongoDB, Neo4j is an added advantage

• Experience with observability tools like Splunk and DataDog

Learn More About ConcertAI

Our team at ConcertAI is dedicated to transforming healthcare decision-making through the application of RWE and AI to improve patient outcomes. We work in a fast-paced, dynamic, high-performing culture where diversity, collaboration, and innovation are valued. Join us on our quest to create a world free of disease. Learn more about ConcertAI at www.concertai.com , or follow us on LinkedIn.

EEO

ConcertAI provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.