Clinical System Designer

2 days ago

Bengaluru Chennai Thiruvananthapuram, India ICON plc Full time ₹ 15,00,000 - ₹ 25,00,000 per year

Role & responsibilities

Excellent functional knowledge of CRF design tools and one clinical data management system, with basic understanding of another CDMS.

• Ability to plan and design CDMS components directly from interpretation of medium complexity clinical trial protocols.

Business Expertise:

• Acts as the primary 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

• Consolidates and completes the high-level system requirements documents and manages their review.

• Responsible for Copying and modifying CRFs from standard libraries and other studies.

• Provides support and review for the re-use of library items.

• Responsible 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

• Creates and maintains standard libraries for all study components.

• Utilizes edit checks from the appropriate library and modify the library edit checks to meet trial specific requirements.

• With assistance, may program dynamic checks and discrepancy edit checks to meet trial specific requirements.

•Assists in the development of materials for the bid defence process and client demonstrations and participate in industry meetings as a representative of ICON.

• 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

• Take part in study kick off (internal and external) meeting as appropriate

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

Preferred candidate profile

  • Advanced degree in a relevant field such as computer science, biomedical engineering, or a related discipline.
  • Extensive experience in the design and implementation of clinical systems within the clinical research industry.
  • Strong leadership skills and proven ability to manage cross-functional teams effectively in a matrix environment.
  • Expertise in data analysis and interpretation, with proficiency in clinical data management systems and software.
  • Excellent communication, interpersonal, and stakeholder management skills, with the ability to influence and drive change in a complex organization.
  • A commitment to maintaining high standards of quality and compliance in all system-related activities.

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