Open Positions at ICON plc

What You Will Be Doing:

• Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials.
• Ensuring protocol compliance, data integrity, and patient safety throughout the trial process.
• Collaborating with investigators and site staff to facilitate smooth study conduct.
• Performing data review and resolution of queries to maintain high-quality clinical data.
• Contributing to the preparation and review of study documentation, including protocols and clinical study reports

Your Profile:

• Bachelor's degree in a scientific or healthcare-related field.
• 3+ years of experience in independent, on site monitoring
• In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidelines.
• Strong organizational and communication skills, with attention to detail.
• Ability to work independently and collaboratively in a fast-paced environment.

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The role

• You will lead/project manage multi-disciplinary teams on assigned projects.
• Be responsible for developing, maintaining and validating standard data structure and software.
• Design and write standard departmental macros that are maintainable, supportable, well-documented programs which are user friendly and accessible.
• Monitor procedures for program development and validation and assist in the training of statisticians/programmers to ensure the development of data analysis skills.

What you need

• Bachelor’s degree in a quantitative or scientific discipline or equivalent, with Master’s degree or PhD preferred.
• Recent experience must be relevant and have primarily been involved in creating and validating analysis datasets (CDISC ADaM standard preferred), Tables, Listings and Graphs.
• Knowledge of a wide variety of technologies.
• Professional leadership skills coupled with exceptional communication skills.

go to method of application »

The role

• You will lead/project manage multi-disciplinary teams on assigned projects.
• Be responsible for developing, maintaining and validating standard data structure and software.
• Design and write standard departmental macros that are maintainable, supportable, well-documented programs which are user friendly and accessible.
• Monitor procedures for program development and validation and assist in the training of statisticians/programmers to ensure the development of data analysis skills.

What you need

• Bachelor’s degree in a quantitative or scientific discipline or equivalent, with Master’s degree or PhD preferred.
• Recent experience must be relevant and have primarily been involved in creating and validating analysis datasets (CDISC ADaM standard preferred), Tables, Listings and Graphs.
• Knowledge of a wide variety of technologies.
• Professional leadership skills coupled with exceptional communication skills.

go to method of application »

What You Will Be Doing:

• Develop and maintain strong relationships with clients, serving as a primary point of contact for communication and support.
• Collaborate with cross-functional teams to understand client needs, develop solutions, and ensure the successful delivery of services.
• Identify opportunities for account expansion and revenue growth, leveraging industry trends and market insights.
• Manage the end-to-end sales process, from lead generation to contract negotiation and close.
• Monitor account performance, track key metrics, and identify areas for improvement to enhance client satisfaction and retention.

Your profile

• Bachelor's degree in business, life sciences, or related field; advanced degree preferred.
• Proven experience in account management, sales, or client services within the pharmaceutical, biotechnology, or clinical research industry.
• Strong understanding of clinical trial operations, regulatory requirements, and industry standards.
• Excellent communication, negotiation, and interpersonal skills, with the ability to build rapport and influence stakeholders at all levels of the organization.
• Results-oriented mindset with a track record of achieving sales targets and driving business growth.

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As a Clinical Research Associate, your primary focus will be on the end-to-end management of clinical trials at assigned study sites. You will:

• Collaborate closely with the local study team to meet study goals, timelines, and site commitments.
• Serve as the primary point of contact for study sites, overseeing the preparation, initiation, monitoring, and closure of clinical trials.
• Ensure compliance with international guidelines (ICH-GCP) and local regulations to guarantee the integrity and safety of the study.
• Proactively identify and resolve study-related issues, escalating as necessary to ensure smooth site performance.
• Conduct monitoring visits (both on-site and remote) and manage essential study documentation.
• Assist in site training, patient recruitment, data management, and quality control to ensure the study runs efficiently.
• Maintain accurate and up-to-date records in CTMS and ensure study sites remain inspection-ready at all times.

We’re searching for a highly motivated individual with:

• Experience: A minimum of 2-3 years of experience as a CRA or in a similar role, preferably across multiple therapeutic areas.CV and Respiratory are an advantage.
• University degree in Health Science, or a related field.
• Compliance Knowledge: Strong knowledge of ICH-GCP guidelines and local regulatory requirements.
• Communication Skills: Excellent interpersonal and communication skills, with the ability to build strong relationships with investigators and site staff.
• Problem-Solving: A proactive approach to identifying and resolving issues while maintaining a high level of attention to detail.
• Adaptability: The ability to work effectively in a fast-paced and dynamic environment, managing multiple priorities with precision.

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What you will be doing:

• Create or review mapping specifications for internal data and/or SDTM.
• Generate or review internal data and/or SDTM datasets using internal conversion framework, utilities, and global checks Ensure quality review of all datasets (e.g., Pinnacle 21 compliance checking); ensure datasets are available for stakeholder use (medical review, central monitoring, adaptive design, etc.) and compliant for interim and final database.
• Program, or oversee programming of, quality review checks and reports for use by Data Managers and other team.
• Responsible for creation of submission-ready SDTM packages for FDA/PMDA or other regulatory authority submissions and keeping abreast in changing regulatory.
• Responsible for acquiring and maintaining working knowledge in the various and future evolving data collection tools applied in the clinical trial space such as Medidata Rave, Clinical Data Tools such as LSAF, Pinnacle 21, and in CDISC standards such as SDTM, CDASH, Controlled terminology and xml.
• Support the development of standards and drive their implementation within the organization.
• Training/Mentoring of flex resources is expected to be done by  higher experience level  when applicable.
• Leading a support team when applicable is expected to be done at the higher experience level.

You are: 

• Bachelor's degree within a Sciences, Computer Science, Engineering or Statisics related fields. 
• Miimum 5 years' experience with SDTM and SAS programming. 
• In depth knowledge of data structures. 
• Experience working in a highly diverse team within clinical research.
• Project management skills. 
• Highly organized with excellent written and verbal communication.