Current Job Opportunities at ICON plc

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:

• At least 2 years of independent, on-site 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
• Ability to work to tight deadlines
• Availability to travel least 60% of the time (international and domestic -fly and drive) and should possess a valid driving license

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Responsibilities:

• Recognize, exemplify and adhere to ICON's values which center on Integrity, Accountability & Delivery, Collaboration, Partnership and Own IT@ICON
• Manage Projects, People and/or Audits relevant to the Functional area as appropriate for the position.
• Recognize, exemplify and adhere to ICON's values which center around our commitment to People, Clients and Performance.
• As a Manager, the employee is expected to recognize the importance of and create a  culture  of process  improvement  with  a  focus  on  streamlining  our  processes  adding  value  to  our  business and meeting client needs.
• Identify changes and be aware of pending changes to GXP industry regulations and guidance’s worldwide.
• Acquire full awareness of sponsor’s book of work, client requirements, SOPs, deliverables, KQIs, KPIs and frequency of reporting.
• Support Review of all client-specific processes and documentation to ensure relevance to current agreements with the client as well as adherence to the processes outlined.
• Facilitates and/or ensures facilitation of all project, client and/or portfolio related quality issues (e.g. CAPAs) and ensures effectiveness checks are instituted in a timely manner.
• Support preparation and management of audits and inspections providing expertise and guidance to gain successful outcomes.
• Drive special projects surrounding Quality or Operations updates that require change management, client communication, and/or process updates.
• Review client related metrics, including assisting in metric collection as needed; investigate and troubleshoot quality issues from internally or externally driven complaints and/or client audits.
• Present at internal and external meetings, including analysis and presentation of Quality data, and respond to questions / requests as applicable.
• Attend Governance level meetings at the required frequency, participate in discussions and/or present quality topics and/or quality data.
• Act in a proactive, flexible and responsive manner to customer needs; communicate with clarity of purposes, setting clear direction.
• Provide innovation or enhancement to existing client relationships – this can include initiating forums to engage internal program teams on quality metrics/trends for their programs, implementing lessons learned for audits or inspection outcomes, partner with client on portfolio level initiatives.
• Advocate for the client with all internal departments to drive process improvement in all relevant areas.
• Proactively identify actions and areas for improvement at the portfolio/ Customer level.
• Provide technical/SME guidance to employees/colleagues and/or customers.
• Actively participate in or lead process improvement initiatives with the Q&C teams/ICON teams and ensure achievement of high-quality standards.
• Identifies and resolves technical and/or operational issues, drawing on company policies and guidelines and identifying exceptions for further review.
• To undertake other reasonably related duties as may be assigned from time to time.

Requirements:

• At least 3-5 years of QA experience in a GCP environment
• Strong stakeholder management skills and proven experience in a sponsor-facing role

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Site Activation Lead

• As a Site Activation Lead at ICON, you would advance clinical trial start-up activities by understanding the client objectives and assist in the development of the plan for country and site distribution. We pride ourselves on our amazing company culture, where we work as one team to achieve industry-leading results.

Role Summary

• Lead clinical trial start-up activities by understanding the client objectives and assist in the development of the plan for country and site distribution
• Oversees day to day delivery of all aspects of site activation in the projects assigned.
• Ensures that each project has a site activation plan and that the study is being conducted in accordance with that plan and in an effective manner which meets sponsor timelines and expectations and is in compliance with ICON/client KPIs, ICON/client SOPs, reporting norms, appropriate regulations and ICON's quality standards
• Lead sponsor initiatives such as kick-off meetings, bid defences, project update and status calls, and other communications
• Utilize project management skills to optimize performance and collaboration to ensure successful study outcomes

What you need for a Site Activation Lead

• Bachelor's Degree preferably in life sciences
• Minimum of 5 year of experience in a Clinical Research environment, focusing on Start Up experience
• Project management skill set
• Understanding of regulatory and submission processes in many different countries
• Excellent written and verbal communication
• Ability to work to tight deadlines

Sr. Site Activation Lead

• As a Senior Site Activation Lead at ICON, you are accountable for driving and accelerating the activation of investigator sites. Additionally you will be accountable for the implementation and completion of site activation activities for global, complex projects. As a Senior Site Activation Lead you will work cross functionally throughout ICON and with ICON sponsors, ensuring a positive customer experience throughout the relationship!

The role

• Primary SSU point of contact for designated global projects and programs
• Accountable for developing successful sponsor relationships, proven through consistently high sponsor satisfaction scores in SSU, contributing to the retention and repeat business.
• Working cross-functionally to ensure sites and countries optimize accelerated delivery of the project
• Risk management and mitigation strategies within site activation to ensure timely delivery
• Ensure stringent oversight of project in terms of timely and quality delivery of key landmarks
• Accountable for management of sponsor expectations and ensuring compliance with ICON / Sponsor critical metrics; SOPs; and quality standards.
• Responsible for the study start up budget, including resources; timelines; rates and margins.

What you need for a Sr. Site Activation Lead

• Bachelor's Degree preferably in life sciences
• In depth proven experience within clinical research, specifically in the clinical studies regulatory environment.
• Excellent Leadership skills, developed with a collaborative approach to driving performance and success
• Experience in successful management and delivery of study deliverables, ideally with proven experience in the oversight of project management and staff in a multi-country / global environment.
• Cross functional leadership and influencing skills
• Strong planning and organization skills within a time pressured environment.
• Excellent written and verbal communication, fluent in English

Benefits of Working in ICON:

• Our success depends on the knowledge, capabilities and quality of our people. That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

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The role:

• The Clinical Trial Manager is responsible for the delivery of all clinical aspects of the study.
• The CTM oversees the clinical portion of the budget, develops monitoring plans & tools, trains CRAs, drives enrolment and study start-up activities, reviews trip reports, implements corrective and preventative action plans, liaises with the Sponsor, vendors & cross-functional teams, identifies & mitigates risks that may impact clinical delivery, and provides reporting & metrics on all clinical activities.
• The CTM will also participate in Sponsor, Investigator and bid defense meetings.

You will need:

• 4 year degree or equivalent combination of education & experience
• Demonstrated ability to drive the clinical deliverables of a study
• Subject matter expertise in the designated therapeutic area
• Prior monitoring experience is preferred
• Ability to travel up to 20%
• Fluent in English

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OVERVIEW OF THE ROLE:

• The Senior Clinical Data Science Lead (Senior CDSL) serves as the primary contact for internal and external team members regarding clinical data science data review activities and leads these review activities to ensure delivery of data fit for analysis.
• They are accountable for achieving clinical data science deliverables on-time, with high-quality, and to agreed financial metrics. 
• Develop and oversee timeliness of clinical data science activities during the life cycle of studies as it relates to data review and data delivery milestones
• Provide input into clinical system development activities and clinical risk management activities
• Track and keep 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
• Forecast budget, hours, and resourcing for clinical data review activities
• Perform analytic review as defined in the scope of work and functional plans focusing on errors that matter or have a meaningful impact on the safety of the subject or interpretation of the final analysis
• Accountable for the development of planning documents related to data review, data analytics, and data deliverables.
• Participate in Sponsor and/or third-party audits.
• Negotiate timelines and key deliverables with clients and/or external customers, vendors, and departments as needed
• Travel (approximately 15%) domestic and/or international

TO BE SUCCESSFUL, YOU WILL NEED:

• 5+ years of clinical data management experience in a clinical research organization or pharmaceutical company
• 2+ years of experience working in a clinical research organization (CRO)
• Experience as a functional lead of multiple low and moderately complex studies, whilst acting as a resource for less experienced colleagues
• Experience with all steps within the data science lifecycle and most major data science study tasks, with proficiency in at least one Clinical Data Management system required (e.g., Medidata Rave, Inform, Oracle Clinical, Veeva)
• Excellent communication skills
• Budget and timeline management experience
• Data Analytic and Data Validation experience
• Bachelor’s degree or local equivalent
• Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write, and speak fluent English and host country