Jobs at ICON plc

What You Will Be Doing:

• Designing and implementing statistical analyses for clinical trials, including the development of statistical analysis plans and interpretation of results.
• Collaborating with cross-functional teams to define study objectives, data requirements, and statistical methodologies.
• Providing expert statistical guidance and support for the development of clinical trial protocols and data analysis strategies.
• Ensuring compliance with regulatory standards and industry best practices in statistical analysis and reporting.
• Mentoring and supporting junior statisticians, fostering a collaborative and innovative environment within the biostatistics team.

Your Profile:

• Advanced degree in Biostatistics, Statistics, or a related field.
• Significant experience in biostatistics within the clinical research industry, with a strong track record in designing and analyzing clinical trial data.
• Proficiency in statistical software and programming languages such as SAS, R, or Python.
• Strong analytical skills with a thorough understanding of clinical trial methodology and regulatory requirements.
• Excellent communication, interpersonal, and organizational skills, with the ability to work effectively with cross-functional teams and stakeholders.

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What you will be doing:

• Has the overall responsibility for the study commitments within the country and for timely delivery of data to required quality.
• Leads Local Study Team consisting of CRA(s), CTA(s), for assigned study/studies
• Coordinates the site selection process by identifying potential sites/investigators, performing initial Site Quality Risk Assessment, and conducting Site Qualification Visits to evaluate suitability and quality risks.
• Ensures timely submission of application/documents to EC/IRB at start up and for the duration of the study.
• Works together with Regulatory Affairs to ensure timely delivery of application/documents for submissions to Regulatory Authority for the duration of the study, and in line with local regulations.
• Ensures all country and site level trial essential documents required by ICH-GCP prior to study start have been collected and verified for correctness, prior to setting sites ready to enroll, and in line with SOPs.
• Sets up and maintains the study in CTMS at study country level as well as local websites as required by local laws and regulations.
• Oversees, manages and coordinates monitoring activities from site activation through to study closure at country and site level in accordance with the Monitoring Plans.
• Reviews monitoring visit reports (as required and following SOPs) and pro-actively advices the monitor(s) on study related matters.
• Performs any required co-monitoring, Accompanied Site Visits/training visits with study CRAs.
• Participates in training and coaching new members of the Local Study Team ensuring compliance with ICH-GCP

You are:

• Bachelor degree in related discipline, preferably in life science, or equivalent qualification.
• Solid experience in Development Operations (CRA, SrCRA) or other related fields
• Excellent verbal and written communication skills.
• Ability to travel as required

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As a CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

• The Global Clinical Study Coordinator MAO, assists with local project management activities of clinical trials from start-up through to closeout activities. Work in close collaboration with the Global Trial leader (GTL) to ensure overall study delivery at the country level.
• Schedules study management team meetings for each project assigned and maintains documentation from meetings.
• Assists in management of project budgets and Affiliate spend, reconciliation of invoices, final budget and liaises with Accounts payable, as necessary.
• Ensures study compliance by maintaining and updating trial management systems, Clinical Trial Management System (CTMS), Trial Master File (eTMF) and Trial Master Source (TMS) ensuring upto-date, complete and accurate status.
• Maintains internal project specific study sites to ensure availability of all central project documents.
• Liaises with external service providers and contract research organizations as needed.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant
  training requirements.
• Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals, if applicable.
• Full utilization by timely and accurate time reporting.

You are:

• Bachelor’s degree or equivalent experience
• Excellent independent time management skills.
• Experience in clinical research experience in the pharmaceutical industry or CRO. At least 1 year in a CTA role.
• Fluency in English

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The Role:

• Our industry leading Global Study Start Up group is growing and we are  currently looking for Senior Site Activation Leads to join our evolving global team.  This is a truly global position which offers the opportunity to lead and manage global or multi regional large scale studies.
• Act as Start Up point of contact for both internal and external stakeholders at a global level
• Take oversight of the development and implementation of the Start Up strategy by the cross functional teams
• Provide support to the Project Manager around financial and resourcing tasks during the Start Up phase of the study.
• Take overall responsibility for and co-ordination of the risk management analysis, mitigations and reporting

The Requirements:

• Here at ICON we want our employees to succeed and ensure that they are set up for this success through constant training, development and support. To enable success in this position you will have:
• A proven track record of success in study start-up activities in either a CRO or pharmaceutical company, including submissions, managing timelines and driving delivery
• Demonstrable study start up experience in regions, such as EMEA, APAC, LATAM at least 5 years.
• The ability to identify risk and make decisions
• Fluency in English
• The ability to communicate confidently and learn quickly are also key attributes.