Clinical System Designer II

Clinical System Designer II - Bengaluru/ Chennai/ Trivandrum Hybrid: Office

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.

• Act as the primary point of contact during study build for design related questions by the project team.
• Read, ensure understanding and adhere to the study protocol, contract and scope of work for all tasks during set-up, maintenance and close-out of the study.
• Track and keep functional management and those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalate potential problems effectively and in a timely manner.
• Consolidate and complete the high-level system requirements documents and manage their review.
• Copy and modify CRFs from standard libraries and other studies; provide support and review for the re-use of library items.
• Develop Custom CRF screens, Edit Check and Dynamic Check specification documents using prototyping methodologies as needed.
• Perform quality control peer reviews of database related specifications as needed and record comments appropriately.
• Lead eCRF and other specification review meetings.
• Create and maintain standard libraries for all study components; utilize edit checks from the library and modify them to meet trial-specific requirements.
• With assistance, program dynamic checks and discrepancy edit checks to meet trial-specific requirements.
• Assist in the development of materials for the bid defence process and client demonstrations and participate in industry meetings as a representative of ICON.
• Obtain required approvals for the release of system components to the live/production environment.
• Review all activity to identify out-of-scope tasks and bring them to the attention of the CSL; support the CSL in negotiation of timelines and decision making on the study.
• Maintain and track meeting minutes, issues and decisions logs, and escalations where appropriate.
• Take part in study kick-off (internal and external) meetings as appropriate.
• Assist in assessing impacts of post-production database changes and compile the change management documentation for review by project team leads.
• Other responsibilities may be assigned as required.
• Leadership: Ability and willingness to assist team members; assess training needs of study team members on an ongoing basis; provide refresher training to junior CSL-level team members as required; review activity and progress of team members; organize and oversee training and mentoring for junior levels; promote process improvement and value for the business and client needs.
• Travel: Approximately 10% domestic and/or international.
• Experience: Typical years of experience 3+. An equivalent combination of education, training and relevant experience may be considered in place of the stated education and experience.
• Problem Solving & Impact: Problems are related but not obvious; perform analysis to identify and define problems; contribute to improvements to CSD systems and processes and help achieve short- to medium-term goals.
• Interpersonal Skills: Strong written and oral communication and presentation skills; strong cross-team communication.

Typical years of experience 3+. An equivalent combination of education, training and relevant experience may be considered in place of the stated education and experience.

Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here.

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply