ICON

Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close. May manage the study start up process in countries assigned and/or oversee CRO responsible for these activities as applicable. Site identification and feasibility ensuring countries/sites can meet all study protocol requirements.

As a Medical Writer, you will author study-level documents, including protocols, subject information, and clinical study reports. You will interpret and summarize data, drive discussions, and incorporate project strategies into documents. The role requires experience in writing regulatory documents for pharma or CRO and strong communication skills.

As a Principal Medical Writer, you'll develop and author clinical and regulatory documents, ensuring compliance with regulatory guidelines and company standards. You'll collaborate with cross-functional teams to interpret clinical data, mentor junior writers, and contribute to developing templates and style guides. Staying current with industry trends and regulatory changes to integrate best practices into medical writing processes is expected.

The Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with clients processes, GCP/ICH and regulatory requirements. This role leads all SSU activities in close collaboration with various managers and the global study team, and in satellite countries, acts as a primary back-up and deputy of the country manager.

As a CTA, you will join the world’s largest & most comprehensive clinical research organisation. The Clinical Trial Assistant plays a fundamental role in the successful execution of global clinical trials, supporting the completion and coordination of various logistical and administrative tasks. Responsibilities include collecting data for regulatory submissions, document tracking, and maintaining relationships with site staff.

In this Creative Production role, you'll support the Creative Lead with design, branding, and marketing activities for the Patient Recruitment and Retention team. You will collaborate with internal and external stakeholders to identify key insights to drive creative programming and development of creative briefs for projects. The role includes designing, executing, and presenting creative concepts, as well as supporting the creation of global patient/HCP deliverables.

Join ICON Bulgaria as a Site Contracts & Budget Negotiator, a sponsor dedicated role focusing on negotiating clinical trial agreements and budgets within Bulgaria, with potential support for other EMEA countries. Responsibilities include negotiating legal and budget terms for Clinical Study Agreements, drafting ancillary site contracts, and ensuring compliance with regulatory requirements. It requires collaboration with sponsors and providing country level intelligence.

The Site Engagement Liaison manages clinical Investigators and sites being considered and participating in sponsors clinical trials and Post Marketing Safety Studies; inclusive of Investigator / site identification and qualification, the timely delivery of clinical trial enrollment, issues management at clinical trial sites, and ensuring inspection readiness.

As a CTMS Business System Specialist, this role focuses on monitoring and maintaining the Veeva Vault CTMS (System) within ICON. The role involves managing the Veeva Vault CTMS, supporting platform configuration, stewarding operational trial data, and partnering with cross-functional teams to streamline study processes, ensuring system compliance and data integrity.

As a Clinical Study Support Specialist, you will organize and deliver analyzable reports and metrics to the clinical study lead. You will schedule and coordinate meetings, prepare agendas, presentation materials and minutes for clinical study team meetings and other study related meetings. The role involves collating data for assessments such as feasibility and site selection, contributing to the review of study documents and manuals, and tracking site activation and enrollment.

An exciting new role with ICON's regulatory team working on high profile Pharma projects, the Regional CTA Submission Manager is accountable for leading operational submissions execution for designated CTAs, and operate as regulatory operational Subject Matter Expert for EU CTR. This role requires hands-on experience in Clinical trial applications under EU CTR.

As a Medical/Clinical Data Reviewer you will be joining the world’s largest & most comprehensive clinical research organisation. You will serve as a Clinical Data Reviewer and identify any errors in data by performing data review that require further clarification with the study sites. You will also perform ongoing review of clinical/medical aspects of assigned patient data and documents.

An exciting new role with ICON within our regulatory team working on high profile Pharma projects. The Regional CTA Submission Manager (CTA-SM) is accountable for working with contributing to business lines to lead operational submissions execution for designated CTAs and may operate as regulatory operational Subject Matter Expert for EU CTR.

As a Clinical Adjudication Project Lead, take a key role in improving the lives of patients by accelerating the development of our customers ' drugs and devices through innovative solutions. Be a dedicated resource to one of our clients, embedded in their working environment, systems, and processes. You will be engaged in a wide range of interesting and challenging tasks overseeing outcome adjudication for cardiovascular and diabetic megatrials.

Join our dynamic team as a Clinical Research Associate at ICON, and play a pivotal role in advancing innovative treatments. Responsibilities include conducting site visits, ensuring protocol compliance, performing data review, and contributing to study documentation.

The Senior Manager Patient Recruitment role serves as the critical link between patients, advocacy groups, and internal clinical teams to ensure that the patient voice is integrated throughout the clinical trial lifecycle. You will be building and maintaining relationships with global and regional patient advocacy groups and individual patient representatives. You will act as the primary point of contact for patient organizations related to clinical trial education and collaboration.

Prepare, negotiate, and finalize clinical trial agreements and ancillary agreements for company sponsored and/or investigator-initiated studies. You will work with global teams to review and analyze contractual terms and conditions. Assess legal and budget risks in conjunction with team support functions. Manage the contract amendment lifecycle. Assume responsibility for all aspects of legal document and metrics tracking.

As a Clinical Data Manager, you'll participate in vendor oversight, represent data management in the Clinical Sub-team, and serve as the first point of contact for CRO partners. You will lead clinical trial data collection set-up, data review, and database lock. The candidate will also track study deliverables, manage external Data Management budgets, and represent the function in external professional initiatives.

As a Medical Affairs Manager, you will continuously monitor all inquiries to external stakeholders and conduct detailed reviews of each inquiry handled by MI associates. You'll provide feedback to MI associates, develop and maintain response databases, and collaborate with cross-functional teams to support products. Responsibilities also include developing and providing therapeutic and product training to internal customers, monitoring metrics for MI activities, and providing inquiry management coverage.

As a CRA, you will monitor multiple Phase I, II, III & IV clinical trial sites, across different therapeutic areas. You will collaborate with the team, developing commitment to study timelines and objectives through regular visits with site staff in-person and remotely. As the first point of contact for study sites, escalating any concerns/issues to other departments.

This position serves as an expert in Study Start Up (SSU) activities and strategy including the use of various clinical systems (e.g. CTMS) to enable consistent and compliant forecasting and data collection. Manage and may lead the day-to-day operations within Study Start Up to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.

Perform processing and oversight of adverse event/drug experience reports (serious and non-serious) and other safety related data for client marketed products and clinical trials. Completion of the case management lifecycle including but not limited to: intake, triage, book-in, data entry, peer/quality review, follow-up and submissions. Perform case processing and data gathering tasks within Argus Safety Database and other client systems. Assist with business partner and other query management.

The SSU Clinical Study Administrator is responsible for ensuring vendor spreadsheets are completed correctly and processed (submitted to vendor or global team) according to study team guidelines. SSU CSA will attend weekly Study Team meetings to report on vendor Spreadsheets. SSU CSA will participate in vendor management activities.

Assists in the coordination and administration of the study activities from the start up to execution and close out, and within the Local Study Team to ensure quality and consistency of interventional study deliverables to time, cost and quality objectives. Collects, assists in preparation, reviews and tracks documents for the application process.

Performs data review of clinical trial data, including query management, and reconciliation review of external data against EDC data. May assist in creating study documents or running study reports and metrics. Files study documentation in electronic Trial Master File (eTMF) and department project files. Assists with quality review of activities performed by the CRO, as needed, and ensures compliance with own Learning Curricula, corporate and/or GXP requirements.