Job Opportunities at ICON plc

Key Responsibilities

• In line with corporate/regional/Clinical Development Centre (CDC) priorities, plan and conduct clinical quality assurance and clinical training activities to ensure that the relevant sponsors’ Clinical QMS (Quality management System) is functioning in compliance with ICH/GCP and local regulatory requirements in Clinical Development Centres (CDC) including the adjacent affiliates reporting to the CDC.
• The role requires the ability to properly implement local/global processes and procedures, to identify opportunities for process improvement and to support improvement initiatives. Be the local expert for ICH-GCP and local regulations and lead continuous quality improvement activities in CDC.

Clinical Quality:

• Plan and conduct activities within the Clinical Development Centre (CDC) to support Inspection/ Readiness at all times

Such as:

• Perform systematic quality checks for key activities such as protocol deviations, informed consent, TMF, etc.
• Ensure Inspection readiness package prepared for the high-risk sites in the CDC.
• Identify re-current issues and ensure preventive actions are implemented.

Quality Control/Compliance Activities
Coordinate Clinical QMR (Quality Management Review) activities in the CDC including:

• Tracking of QMR actions and focus area in CDC.
• Collects and monitors compliance issues and escalates, compliance issues including trends to the CDC.
• Performs root cause analysis if required.
• Developing local action plan and sharing of results and training of local affiliate, if required.
• Perform clinical quality and support visits (CQSV) to clinical trial sites in alignment with the regional/CDC/affiliate.
• Bachelor's Degree or equivalent in relevant health care area.

Experience:

• A minimum of 5 years of relevant experience in clinical research including direct field monitoring experience plus 2 years of QC Management experience.
• Knowledge and understanding of Clinical Trial processes as well as quality management and control tools is required.
• Solid track record of initiating, planning and delivery of projects and knowledge of project management practices.
• Experience of participating in cross-functional teams of business professionals.
• Experience of participating in audits and inspections.
• Must have worked in a Clinical setting in Sub-Saharan Africa countries and be based in South Africa.
• 50% of role requires travel to Sub-Saharan Africa.

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Summary of SDTM Programmers’ responsibilities:

• Interact with vendors to receive CRF & external data. Review data transfer specs to ensure data is in a form we can use (SAS compliant variable names, follow Otsuka standards and specific compound templates, file format is something we can use with little manipulation).
• Review CRF & external data received. Compare datasets and vendor annotated CRF to ensure all expect fields are captured – these datasets are then used to build the SDTM datasets.
• Write SAS programs to compare CRF data and External data (LAB, ECG, PK, EEG…) – compare subject id, visit, date, time, accession number. Reports are then given to data managers for reconciliation and to issue queries.
• Create Trial Design Domains based on protocol/CRF.
• Use a GUI interface (DSP) to create SDTM datasets. Using a series of boxes following arrows across the screen to layout the flow of data and the computations needed. This is “SAS-like” but is not using SAS directly to program the SDTM datasets. When you execute what is created in GUI environment, the system then writes SAS code to build the datasets. Takes some detective work to figure out what went wrong by looking at temporary and output datasets, and behind-the-scenes SAS code that gets written.
• Create SDRG and SDTM define
• QC SDTM datasets, specs, docs, annotations that other programmers create.
• Troubleshooting and SAS programming to create tools for the team – such as create a SAS programs to convert .csv/.xlsx/.dat files to SAS datasets. Or create programs to do full Proc Compare of a study’s database (new data versus old data) that can be used as a standard across studies.
• Interacting with data managers, clinical programmers, statisticians, medical coders, external data vendors.
• Running Pinnacle 21 to validate SDTM datasets.

Qualification:

• 5 years' experience working with SDTM
• University or college degree in Life Sciences, Mathematics, Computer Science, Medical Informatics or equivalent degree
• Bases SAS programming skills and Certified SAS Programmer are most preferred.
• Attributes: well versed in building, mapping, annotating, QC’ing, and understanding flow of SDTM data. Attention to detail. Problem solver. Good at working in teams. Familiar with writing code for edit checks and data reconciliation. Good documentation practices.