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- Leads study specific database design projects within the InForm CDMS system, leading clinical database programming activities on multiple studies of complex design
- Reviews database specification documents created by study teams, such as CRF Specifications and Data Validation Specifications (DVS)
- Builds clinical study database CRF screens per CRF Specifications provided by project team
- Creates/Programs edit checks, special actions/functions, custom programs and derivations as per a DVS
- Plans and schedules edit check test script writing, edit check programming and edit check validation with the centralized CDMS Testing group and centralized CDMS Programming group. Manages timelines for edit check process, ensures issues are addressed in a timely manner to meet timelines and produces edit check validation packages for delivery to the study teams to file in the Trial Master File
- Completes study database updates as specified per Change Request documents and procedures. Performs an Impact Analysis and Risk Assessment of the proposed changes
- Configures study specific data interfaces such as IVRS, labs, and CTMS.
- Serves on project teams to coordinate and lead CDMS activities for clinical database programming projects. Attends meetings, participates in discussions, uses an analytical approach to problem solving, focuses on deliverables, and provides constructive criticism. Keeps those responsible for project management informed of any issues that might impact project target dates, scope or budget and escalates potential problems effectively and in a timely manner. Balances multiple task assignments and communicates needs to supervisor to obtain needed resources
- Trouble-shoots and solves study building issues and/or system integration issues (such as IVRS failures, CTMS issues), and/or change request issues using the appropriate applications
- Creates advanced CDMS custom programs as per DVS, as required
- May participate in study team meetings as an ad hoc study team member to advise study team on best approach/tool for data collection, to determine scope and limitations of the study and to discuss edit checks, derivations, testing and reports
- Ensures high quality deliverables by providing senior review of study-level/program -level I multi study core deliveries for accuracy
- Participates in special projects or tasks related to the assigned CDMS as directed by the CDMS Manager, as required. This can involve taking ownership of planning, maintenance and delivery of special projects while keeping management informed of the progress
- Maintain confidentiality of management information as appropriate
- To participate and contribute towards internal user group meetings to share knowledge and providing latest updates/features. Participate in Data Management department initiatives.
- Plan for the study execution in detail thereby providing clarity on all aspects of the setup progress (Round 1 programming date, testing dates, UAT dates)
- To act as a bridge between the Clinical Data Programmers and Validation Group within CDMS. Addressing technical clarifications and providing guidance as needed
- Maintaining all necessary study documentation for the CRF build and edit check
- Keeps up-to-date with all software developments and release notes of assigned primary CDMS system. Research and self-training is required to ensure that CDMS knowledge, particularly in relation to system functionality, is current
- Ensures all queries to the CDMS group are responded to in a timely manner, particularly when trouble-shooting an issue or answering a system functionality question. Ensures that queries that cannot be resolved are routed to the correct SME and the issue is pursued until resolved
- Proven experience in building study databases using InForm CDMS
- Team player with strong verbal and written communication skills
- Demonstrated ability to learn new technologies, applications and techniques
- Knowledge of database concepts
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Inside ICONContent type
BlogsPublish date
04/18/2024
Summary
Endometriosis Awareness: A Vital Cause In March, ICON, through its Networking Organization for Women (NOW) employee resource group, joined the global effort to raise awareness about endometriosis
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IndustryContent type
BlogsPublish date
04/18/2024
Summary
Introduction to Data Management in Clinical Trials In the field of clinical research, data management plays a crucial role in ensuring the success and accuracy of clinical trials. Clinical trials
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IndustryContent type
BlogsPublish date
04/12/2024
Summary
Introduction to the Clinical Research Supply Chain The clinical research supply chain plays a crucial role in the successful execution of clinical trials. It encompasses a complex network of activ
Who we are
Salary
Location
Taiwan
Department
Clinical Trial Management
Location
Taiwan
Remote Working
Remote
Job Categories
Clinical Trial Management
Job Type
Permanent
Description
Job Title: Local Trial ManagerWorking location: Home based ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment drivin
Reference
2024-110017
Expiry date
01/01/0001
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Salary
Location
Taipei
Department
Clinical Monitoring
Location
Taipei
Remote Working
Remote
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
Senior Clinical Research AssociateWorking Location: Taiwan Home Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environ
Reference
2024-110013
Expiry date
01/01/0001
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Salary
Location
Taiwan
Department
Clinical Monitoring
Location
Taiwan
Remote Working
Remote
Job Categories
Clinical Monitoring
Job Type
Permanent
Description
Clinical Research AssociateWorking Location: Taiwan Home Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment dr
Reference
2024-110015
Expiry date
01/01/0001
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Salary
Location
Japan
Department
Regulatory, Drug Safety/ Quality Assurance & Other roles
Location
Japan
Job Categories
Drug Safety
Job Type
Permanent
Description
・成長性の高い両社の統合により、世界で1-2位を争う規模のグローバルCRO（世界で40,500名規模、日本で1,000名規模）に拡大・補完的な統合にもとづく、クライアントポートフォリオの多様化がもたらす本格的なスケールメリットの実現 ・さまざまな疾患領域への深い知識をはじめとする、両社が育んできた強みを活かした幅広い／質の高いソリューションの提供・最先端のテクノロジーに、スケールメリットが加わるこ
Reference
2024-109907
Expiry date
01/01/0001
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Salary
Location
Japan
Department
Biometrics Roles
Location
Japan
Remote Working
Remote
Job Categories
Statistics
Job Type
Permanent
Description
・成長性の高い両社の統合により、世界で1-2位を争う規模のグローバルCRO（世界で40,500名規模、日本で1,000名規模）に拡大・補完的な統合にもとづく、クライアントポートフォリオの多様化がもたらす本格的なスケールメリットの実現 ・さまざまな疾患領域への深い知識をはじめとする、両社が育んできた強みを活かした幅広い／質の高いソリューションの提供・最先端のテクノロジーに、スケールメリットが加わるこ
Reference
2024-109186
Expiry date
01/01/0001
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Salary
Location
Mexico, Mexico City
Location
Mexico City
Remote Working
Office Based
Job Categories
Study Start Up
Patient Recruitment
Job Type
Permanent
Description
At ICON, it’s our people that set us apart. Our diverse teams enable us to become a better partner to our customers and help us to fulfil our mission to advance and improve patients’ lives. Our ‘Own I
Reference
JR117283
Expiry date
01/01/0001
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