Latest Vacancies at ICON plc

The Role:

• Working independently and actively to coordinate activities to set up and monitor a study, completing accurate study status reports and maintaining study documentation 
• Submission of protocol, consent documents for ethics/IRB approval and assist in preparing regulatory submissions as requested 
• Balancing sponsor generated queries efficiently, manage and support sites and responsible for study cost-effectiveness 
• Dependent on level of experience you may assist in training and mentoring less expert CRA’s

To be successful in the role, you will have:

• At least 12 months of independent, on-site monitoring experience
• Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
• Great command of the local language and) English (command of any other languages will be considered an advantage
• Ability to produce accurate work to tight deadlines within a pressurized environment
• You will be asked to travel around 60% of the time domestically (on rare occasions internationally) and should possess a valid driving license

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Responsibilities

• Lead the planning and implementation of cross-functional eCOA project(s).
• Facilitate the definition of eCOA project scope, goals and deliverables.
• Define project tasks and resource requirements.
• Develop full-scale cross-functional eCOA project plans.
• Assemble and coordinate project staff.
• Share expert knowledge of eCOA implementation based on study protocol.
• Plan and schedule eCOA project timelines.
• Manage project budget.
• Develop and Manage Risk Mitigation Strategies for eCOA projects.
• Track project deliverables using appropriate tools.
• Provide direction and support to project team.
• Constantly monitor and report on progress of the project to all stakeholders.
• Manage eCOA quality issues.
• Present reports defining project progress, problems and solutions.
• Implement and manage project changes and interventions to achieve project outputs.
• Project evaluations and assessment of results.
• Other duties as assigned.

Education, skills and experience required 

• Bachelor’s degree in related field or equivalent experience
• Minimum of 3 years’ experience in IRT/eCOA or related field
• You will have significant experience in eCOA, research technology, Outcomes Research, or eClinical/Clinical field or related services/industry.
• Comfortable managing a variety of tasks at one time
• Strong leadership, influencing, and motivational skills
• Excellent communication skills
• Fluency in English both verbal and written
• Analytic, problem-solving skills
• Focus on continuous improvement

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Responsibilities:

• Planning, managing and execution of statistical programming deliverables in clinical trial and non-trial activities in the project
• Providing input to authority required documents for the trial and non-trial activities
• Ensuring that clinical trial and non-trial tasks are aligned with the project specifications
• Responsibitly for continuous development of own skills and to contribute to the development of Biostatistics
• Providing programming input to the setup of the trial, including but not limited to the CRF, Trial Validation Plan and Data Flow Plan
• Ensuring that mock TFLs are created and reviewed by stakeholders
• Making AdaM programming according to industry standard and NN specifications
• Ensuring that programming, also by co-workers and functional suppliers, is done according to specifications
• Ensuring that the inspection readiness documentation is updated at all time during the trial life cycle

Required skills and experience:

• +3 years of statistical programming, and preferably 1 year within the pharmaceutical industry or equivalent knowledge through relevant experience
• Extensive experience with programming in e.g. SAS or R
• Experience with reporting clinical trials, including statistical data handling, analysis and reporting
• Experience with review and documentation of programs
• Good knowledge of drug development
• Experience with clinical database technologies, data models and advanced programming
• Experience with collaboration across professional and regional borders
• Regular experience with communication and presentations
• In-depth knowledge of computer systems and IT
• Good knowledge of GxP and guidelines within drug development