Clinical Support Engineer

Project – the aim you’ll have:

The client's platform is a cutting-edge solution for digital health and clinical trials. It specializes in decentralized trials, focusing on patient-centricity and diversity. The platform offers real-time data capture, telemedicine integration, and seamless connectivity with medical IoT devices. It ensures robust interoperability, global scalability, and regulatory compliance. By enhancing efficiency and inclusivity, client's platform is transforming clinical research, making trials more accessible and adaptive to global health challenges.

Position – how you’ll contribute:

• Use technical, industrial, and interpersonal skills, with some support from project team leads and their people leader, to interpret clinical protocols and customer requirements in order to create Patient Platform designs and non-Patient Platform component specifications to meet the needs of the customer and the clinical trial.
• Responsible for optimal design decisions and the utilization of client specific standards.
• Responsible for user management and technical support investigation

Requirements

Expectations – the experience you need:

• Knowledge in identifying bugs or configuration issues
• Understanding of helpdesk systems and support triage process
• Experience working in highly regulated systems and environments
• Good functional knowledge of at least one clinical data management system and CRF design tool/eCOA platform and design tool
• Ability to plan and design Patient Platform components directly from interpretation of low to medium complexity clinical trial protocols.
  Business Expertise:
• Acts as first point of contact during study build for assigned projects for design related questions by the project team.
• Read, ensure understanding and adhere to the study protocol, contract and scope of work for all task during set-up, maintenance and close-out of the study.
• Tracks and keeps functional management and those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalates potential problems effectively and in a timely manner
• With support, consolidates and completes the high-level system requirements documents and facilitates their review.
• Assumes responsibility for copying and modifying eDiaries/eCOAs from standard libraries and other studies.
• Performs quality control peer reviews of database related specifications as needed and records comments appropriately.
• Lead specification review meetings
• Obtains required approvals for the release of system components to the live/production environment.
• Maintain and track meeting minutes, issues and decisions logs, and escalations where appropriate
• May take part in study kick off (internal and external) meeting as appropriate
• With support from other project team leads, assist in assessing impacts of post-production database related changes and compiling the change management documentation for review by project team leads.