Clinical System Designer II
- Bangalore, Chennai, Trivandrum, Bengaluru
- ICON Full Service & Corporate Support
- Clinical Systems
- Office Based
Talent Acquisition Business Partner
- Full Service Division
About the role
This vacancy has now expired. Please see similar roles below...
Functional Knowledge:
• 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
Leadership:
• Ability and willingness to assist team members.
• Assess the training needs of study team members on an ongoing basis
• Provide refresher training to junior CSl level team members as required
• Review the activity and progress of team members who have been delegated activity
• Organizes and creates training and helps to oversee and administer training and mentoring for junior levels.
• 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 3+. An equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated
Problem Solving:
•Problems are differing but related. Solutions are not readily apparent. Undertakes analysis and investigation to identify and define problems.
• Assists with the development and implementation of improvements to CSD systems and processes.
Impact:
• 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.
Interpersonal Skills:
• Strong written and oral communication and presentation skills.
• Strong inter/cross-team communication skills.
Impactful work. Meaningful careers. Quality rewards.
At ICON, our employees are our greatest strength. That’s why we are committed to empowering you to live your best life, both inside and outside of work. Whether your ambition is lead a global team, become a deep scientific or technical expert, work in-house with our customers or gain experience in a variety of different ICON functions, we will support you in realising your full potential. See all locations Read more
Day in the life
Similar jobs at ICON
Salary
Location
UK, Swansea
Location
Dublin
Swansea
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Systems
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
JR123756
Expiry date
01/01/0001
Author
Rikky PethersAuthor
Rikky PethersSalary
Location
United Kingdom
Department
Biometrics Roles
Location
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
2024-114690
Expiry date
01/01/0001
Author
Matt BarkerAuthor
Matt BarkerSalary
Location
Mexico, Mexico City
Location
Bogota
Mexico City
Remote Working
Hybrid: Office/Remote
Business Area
ICON Full Service & Corporate Support
Job Categories
Clinical Systems
Job Type
Permanent
Description
Senior Clinical System Designer Responsibilities:Lead CRF design and manage 2+ clinical data management systems.Interpret clinical trial protocols to design CDMS components.Serve as primary point of c
Reference
JR125042
Expiry date
01/01/0001
Author
Muna NelkeAuthor
Muna NelkeSalary
Location
South Africa, Spain, Poland, United Kingdom
Department
Biometrics Roles
Location
Poland
South Africa
Spain
UK
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
2024-114437
Expiry date
01/01/0001
Author
Matt BarkerAuthor
Matt BarkerSalary
Location
United States
Department
Biometrics Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotech
Reference
2024-114347
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie PruittSalary
Location
United States
Department
Biometrics Roles
Location
United States
Remote Working
Remote
Business Area
ICON Strategic Solutions
Job Categories
Clinical Data Management
Clinical Data Scientist Lead
Clinical Systems
Data Standards Consultant
Job Type
Permanent
Description
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
Reference
2024-114318
Expiry date
01/01/0001
Author
Jamie PruittAuthor
Jamie Pruitt