• Serves as the clinical trial lead responsible for the planning, conduct and oversight of the operational portion of clinical studies • Primary clinical point of contact with the client • Collaborate with PM on monthly invoicing and variance management of clinical budget • Develop study related clinical documents • Identify and develop training needs for CRAs and third-party vendors • Generate potential site list from key stakeholders and drive site feasibility process • Identify potential risks to the enrollment targets • Develop timely and effective communication and good working relationships with investigators and study team • Lead internal clinical team meetings and sets expectations for clinical team • Address all CRA and site questions and maintains Frequently Asked Question (FAQ) log • Support in planning and conducting investigator meetings • Review and/or approve of IP release packages • Oversee, support and track all submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies for assuring study timelines are met • Responsible for eTMF implementation and management • Collaborate with PM, CRAs and QA to develop any Corrective and Preventative Action Plan (CAPA) • Assist sites, internal staff and CRAs with preparation for GCP audits • Work closely with PM for project-specific resourcing issues • Escalate pertinent CRA performance and site compliance issues • Collaborate with data management and CRAs to ensure data quality • Manage processes for investigational product (IP) including drug accountability and reconciliation • Supports business development and marketing activities

Support clinical pharmacology activities by contributing to study design, developing proficiency in pharmacokinetics, and collaborating on drug development teams to enhance insights for informed decision-making in drug development.

• Independently executes statistical aspects of projects that meet client expectations. • Provide one-on-one mentorship to new employees and coops. • Assists in the training of junior statisticians to develop methodological expertise, soft skills, and other aspects of professional development. • Development of statistical analysis plans. • Conducts statistical analyses. • Report development. • Interpretation and dissemination of findings. • Oversees and implements quality control activities. • Lead or participate in the develop or modification of novel statistical analysis code. • Creates, maintains, or extends R packages and R shiny applications to standardize common statistical routines and enable their accessibility, using Git for version and BitBucket for collaboration. • Participating in meetings with clients and/or internal project teams to lead discussions around statistical methods and to present results from analyses. • Demonstrate a commitment to diversity, equity, and inclusion through continuous development, modeling inclusive behaviors, and proactively managing bias.

Role Description As a CTA at ICON, you will support the design, implementation, and management of clinical trials, contributing to the advancement of innovative treatments and therapies. - Contribute to clinical coordination activities, taking responsibility for your deliverables and working collaboratively. - Assist in the planning, execution, and monitoring of clinical trials, ensuring adherence to protocol requirements, regulatory guidelines, and industry standards. - Coordinate study activities including site initiation, patient recruitment, data collection, and monitoring visits to ensure timely and accurate data collection and documentation. - Collaborate with cross-functional teams including Clinical Operations, Data Management, and Biometrics to support the successful execution of clinical trials. - Maintain comprehensive study documentation and records, ensuring compliance with applicable regulations and standard operating procedures. - Support study close-out activities including data cleaning, analysis, and preparation of clinical study reports. Qualifications - Bachelor's degree in a relevant scientific discipline or healthcare-related field. - Previous experience in clinical research or healthcare, preferably within the pharmaceutical, biotechnology, or CRO industry. - Strong organizational and time management skills, with the ability to prioritize tasks and manage competing priorities effectively. - Excellent attention to detail and problem-solving abilities, with a commitment to ensuring data accuracy, integrity, and compliance. - Effective communication and interpersonal skills, with the ability to collaborate cross-functionally and build strong relationships with study teams and clinical sites. - Willingness to travel as needed. Requirements - Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Benefits - Competitive base salary and performance related incentives. - Health and wellbeing programmes including medical, dental, and vision coverage where applicable. - Retirement and pension plans. - Life assurance and disability coverage. - Employee assistance programmes and wellbeing resources. - Learning and development opportunities through structured training and career pathways. - Benefits may vary depending on role and location. Company Description ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.