Job Vacancies at ICON plc

• As a Clinical System Lead you would lead and direct one or more project teams in the planning, development, implementation and go-live of clinical system solutions for our biotech and pharmaceutical customers.

Responsibilities:

• Serves as the primary contact for internal and external team members regarding clinical system development activities
• Tracks milestones, tasks and the overall budget for clinical system delivery
• Participates in Sponsor and/or third party audits
• Forecasts budget, hours and resourcing for clinical system development tasks
• Develops plans and oversees timelines for activities between receipt of protocol and go live of EDC and associated clinical system technologies
• Owns and is responsible for achieving on time release to production of the standalone and integrated clinical system technologies
• Responsible for documenting and overseeing implementation of changes to clinical system technologies
• Responsible for managing Third-Party technology providers and the setup of their systems within PRA
• Ensures quality-control steps are implemented so that quality deliverables are provided, including peer review of the eCRF
• Strong knowledge of Clinical Data Management Systems, computerized information systems and standard application software (Windows, MS Office)
• Strong knowledge of clinical data management
• Contributes to bid and proposal development and participates in bid defense

Experience:

• Minimum 3 years of project management experience required
• At least 2 years working in a CRO within the last 5 years is required
• Experience in leading 3 or more projects simultaneously
• Project management experience, including management of timelines, is essential
• Excellent communication skills
• Budget experience is required
• Experience with all steps within the data management lifecycle and most major data management study tasks, with proficiency in at least one Clinical Data Management system required. Familiarity with Rave is desired.
• Bachelor’s Degree (or international equivalent) OR equivalent work experience preferred

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• As a Clinical Research Associate at ICON, you’ll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II – IV, ensuring adherence to applicable regulations and principles of ICH-GCP. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

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
• Participate in preparing and reviewing study documentation and feasibility studies for new proposals as required
• Balancing sponsor generated queries efficiently and responsible for study cost-effectiveness
• Dependent on level of experience you may assist in training and mentoring less expert CRA’s and/or lead CRA’s working on international projects

What you need

• 18 months+ of monitoring experience in phase I-III trials as a CRA
• Knowledge of ICG GCP guidelines and expertise to review and evaluate medical data
• You will possess excellent written and verbal communication in English
• Ability to produce accurate work to tight deadlines within a pressurized environment
• You will be asked to travel at least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license

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• If you’re as driven as we are, join us. You’ll be working in a dynamic and supportive environment, with some of the brightest and the friendliest people in the sector, and you’ll be helping shape an industry.

The role:

• Become familiar with ICON’s SOPs/WPs, ICH GCP guidelines, appropriate regulations, ICON systems and the principles of and assist with investigator recruitment
• Maintain timelines and ensure accuracy and completeness of data entered into ICON systems
• Serve as the primary in-house contact for sites and investigators participating in studies
• Conduct and completes remote site management activities, with support as needed, according to applicable SOPS and the Study Monitoring Plan.
• To contact Clinical sites for specific requests (e.g. enrolment updates, missing documentation, data entry timeliness, data query follow-up, CDA finding follow-up, and action Item resolution or other sponsor specific CRA tasks.
• Take responsibility for project tasks and sees these tasks through to successful completion, with support.
• Maintain a professional interpersonal relationship with study team, sites, and Sponsors
• Participate in QA Audits as needed.
• Regularly attend and gives to project specific and departmental meetings
• Ability and willingness to travel as needed (drive and fly)
• Maintain Sponsor and patient confidentiality
• Other duties as assigned

You will need:

• Minimum Bachelor's degree in a life science
• At least 12 months of a CTA/Clinical Trial Assistant or similar role experience within the clinical/pharmaceutical industry
• Understanding of ICH GCP Compliance
• Excellent communication and organizational skills
• A phenomenal teammate

go to method of application »

• As a Clinical Research Associate at ICON, you'll work within a large-scale, fast-paced environment alongside a close-knit team of highly qualified CRAs to identify, select, initiate and close-out investigational sites for clinical studies in phases II - IV, ensuring adherence to applicable regulations and principles of ICH-GCP.

The Role:

• Independent, proactive work to set up and monitor studies, complete reports and maintain documentation
• Submitting protocol, consent documents for ethics/IRB approval, as well as preparing regulatory submissions
• Balancing sponsor generated queries
• Taking responsibility for study cost efficiency
• Preparation and review of study documentation and feasibility studies for new proposals
• Potential to assist in training and mentoring fellow CRAs

You will need:

• 18 months+ of monitoring experience in phase I-III trials as a CRA
• College degree in medicine, science, or equivalent
• Previous monitoring experience in medium-sized studies, including study start-up and close-out
• Knowledge of ICH-GCP guidelines and ability to review and evaluate medical data
• Excellent written and verbal communication in Local language and English
• Ability to work to tight deadlines
• Availability to travel
• Oncology experience