Clinical System Designer Job at iconplc (Bangalore)

Job Description

Clinical System Designer - India. ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Clinical System Designer I to join our diverse and dynamic team. As a Clinical System Designer I at ICON, you will assist in the development and implementation of clinical systems that facilitate efficient data collection and management for clinical trials. Your role will be essential in supporting the design and optimization of systems to ensure they meet the needs of users and comply with regulatory standards.

Job Responsibility

Uses 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 clinical data management system (CDMS) designs and non-CDMS component specifications (including electronic Case Report Forms (eCRFs), dynamic eCRF functionality and eCRF edit checks) to meet the needs of the customer and the clinical trial
Responsible for optimal design decisions and the utilization of ICON/client specific standards
Good functional knowledge of at least one clinical data management system and CRF design tool
Ability to plan and design CDMS components directly from interpretation of low to medium complexity clinical trial protocols
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 CRFs from standard libraries and other studies
Assumes responsibility for development of Custom CRF screens, Edit Check and Dynamic Check specification documents, using prototyping methodologies as needed
Performs quality control peer reviews of database related specifications as needed and records comments appropriately
Lead eCRF and other specification review meetings
Recommends updates to the standard libraries for all study components
With assistance, utilize edit checks from the appropriate library and modify library edit checks to meet trial specific requirements
Obtains required approvals for the release of system components to the live/production environment
Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the CSL
Support the CSL in negotiation of time lines and decision making on the study
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
Other responsibilities may be assigned as required
Ability and willingness to assist team members
Embrace and contribute to a culture of process improvement with a focus on streamlining processes and adding value to the business and client needs
Travel (approximately 10 %) domestic and/or international
Typical years of experience 5 years+. An equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated
Problems are varied and nonroutine. Uses previous experience to identify most appropriate solution
Contributes to the achievement of goals through personal effort and influence over others. Impact is focused on the achievement of short- to medium term goals
Good written and oral communication and presentation skills
Good inter/cross-team communication skills.

Requirements

Uses 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 clinical data management system (CDMS) designs and non-CDMS component specifications (including electronic Case Report Forms (eCRFs), dynamic eCRF functionality and eCRF edit checks) to meet the needs of the customer and the clinical trial
Responsible for optimal design decisions and the utilization of ICON/client specific standards
Good functional knowledge of at least one clinical data management system and CRF design tool
Ability to plan and design CDMS components directly from interpretation of low to medium complexity clinical trial protocols
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 CRFs from standard libraries and other studies
Assumes responsibility for development of Custom CRF screens, Edit Check and Dynamic Check specification documents, using prototyping methodologies as needed
Performs quality control peer reviews of database related specifications as needed and records comments appropriately
Lead eCRF and other specification review meetings
Recommends updates to the standard libraries for all study components
With assistance, utilize edit checks from the appropriate library and modify library edit checks to meet trial specific requirements
Obtains required approvals for the release of system components to the live/production environment
Review all activity on an ongoing basis to identify out of scope tasks and bring to the attention of the CSL
Support the CSL in negotiation of time lines and decision making on the study
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
Other responsibilities may be assigned as required
Ability and willingness to assist team members
Embrace and contribute to a culture of process improvement with a focus on streamlining processes and adding value to the business and client needs
Travel (approximately 10 %) domestic and/or international
Typical years of experience 5 years+. An equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated
Problems are varied and nonroutine. Uses previous experience to identify most appropriate solution
Contributes to the achievement of goals through personal effort and influence over others. Impact is focused on the achievement of short- to medium term goals
Good written and oral communication and presentation skills
Good inter/cross-team communication skills.

What we offer

Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

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