ICON plc

Recruitment

• Collaborating with hiring managers to understand talent needs and develop effective recruitment strategies tailored to specific roles.
• Managing the end-to-end recruitment process, ensuring a seamless experience for candidates and hiring teams.
• Utilizing data-driven insights to evaluate recruitment metrics and identify areas for improvement in the hiring process.
• Building and maintaining strong relationships with internal stakeholders and external talent sources to enhance our talent pipeline.
• Staying current with industry trends and best practices in talent acquisition to drive continuous improvement and innovation.

Talent Acquisition Business Partner

• Leading the preparation and submission of regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications.
• Coordinating and liaising with internal and external stakeholders to obtain necessary approvals and authorizations for study initiation.
• Managing and maintaining comprehensive and accurate records of regulatory submissions, approvals, and correspondence.
• Providing guidance and support to study teams on regulatory requirements and best practices for study start-up activities.
• Participating in process improvement initiatives to streamline study start-up processes and enhance efficiency.

Site Activation Partner – SAP

Compliance

• Participate in provision of regulatory expertise in strategic drug development across multiple areas.
• Take part in preparation of strategic development and submission plans.
• Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients.
• Represent the Regulatory Affairs Department in business development activities and generate new business opportunities.
• Contribute to at least two of the following areas: interactions with regulatory agencies, early phase consulting, development planning, scientific/agency advice, orphan drugs/pediatric development, medical devices, regulatory intelligence, due diligence, strategic CT support/GCP compliance, biological/biotech/biosimilars, small company support (incl. SOPs development etc.).

Ad-Promo Regulatory Manager

Project Manager

• Developing and managing detailed project plans, including timelines, budgets, and resource allocation to ensure successful project delivery.
• Leading cross-functional project teams, coordinating efforts to meet project objectives, and facilitating effective communication and collaboration.
• Monitoring project progress, identifying potential risks and issues, and implementing strategies to address challenges and keep projects on track.
• Engaging with stakeholders to manage expectations, provide updates, and ensure alignment with project goals and organizational objectives.
• Preparing and presenting project reports, status updates, and performance metrics to senior management and other stakeholders.

Project Manager – CNS/Rare Diseases

Manager

• Serve as the company’s Internal Prevention Coordinator, ensuring full adherence to all Spanish Health & Safety decrees and laws.
• Act as the primary point of contact for the Servicio de Prevención Ajeno (SPA) and the Labor Inspectorate.
• Maintain the Prevention Plan, Risk Assessments, and Emergency & Evacuation Plans for all ICON Spanish sites.
• Develops, Implements and controls site specific Health & Safety policies and procedures based on local guidelines and corporate policies.
• Keep up to date with changes in current legislation and to bring to the attention of ICON.
• Implement and be responsible for the delivery of the Environmental Health and Safety Management System and updating the systems and policies as the business requires.
• Ensure standardized Environmental Health and Safety inspections are carried out in all locations.
• Direct, manage and provide expertise for incident investigations, case management, near misses, environmental and/or equipment damage.
• Act as a consultant for local Office Managers in 90+ locations to ensure they meet local safety standards and corporate KPIs.

Environmental, Health & Safety Manager

Business Intelligence Developer

• Collaborating with stakeholders to gather requirements and design Tableau & CRM Analytics (Salesforce) data models and visualization solutions.
• Developing and maintaining ETL (Extract, Transform, Load) and Data Flows (Recipes) processes to ensure data integrity and accessibility.
• Creating interactive dashboards and reports to present insights and findings to internal and external stakeholders.
• Utilizing advanced analytics techniques to analyze commercial (Sales) & clinical trial data and identify trends and patterns.
• Providing support and training to end-users on BI tools and functionalities.

Clinical Operations

• Developing and executing project plans, focusing on achieving project goals and objectives.
• Leading cross-functional teams to ensure the successful implementation of project activities.
• Collaborating with stakeholders to identify project requirements and define project scope.
• Mentoring and guiding team members, fostering a culture of excellence and continuous improvement.
• Driving the development of project documentation and reports to present findings to stakeholders in a clear and actionable manner.
• Staying abreast of industry trends and emerging technologies to integrate best practices into project management strategies.
• Contributing to organizational growth through effective project leadership and strategic planning.

Senior Clinical Project Manager, Quality

Director

• Developing and implementing strategic plans for your therapeutic area that align with ICON Plc’s mission and objectives, focusing on innovation and excellence in clinical development and operations.
• Overseeing the design and execution of clinical programs and trials, ensuring they meet regulatory requirements and scientific standards.
• Collaborating with internal and external stakeholders to drive therapeutic area strategy, address challenges, and enhance program outcomes.
• Ensuring compliance with industry regulations, ethical standards, and internal policies, and implementing best practices in therapeutic area management.
• Staying informed about industry trends, scientific advancements, and emerging practices to continuously improve strategies and maintain a competitive edge.
• Providing strategic leadership and direction to drive innovation and support the organization’s goals within your therapeutic area.

Senior Director, Therapeutic Area – Oncology

Research Analyst

• Hands-on involvement across Phase I study start-up, conduct, and close-out
• Monitor Phase I clinical trials (on-site and remote)
• Support study start-up, site activation, and ongoing site management
• Autonomy to manage sites and priorities in a dynamic environment
• Exposure to complex early-phase activities and decision-making
• Ensure protocol compliance, data integrity, and GCP adherence
• Proactively identify and resolve site and study-level issues
• Partner closely with Clinical Operations and cross-functional teams

Senior Clinical Research Associate, Sponsor Dedicated

Software Engineer

• Developing and validating SAS programs for statistical analysis and reporting of clinical trial data.
• Collaborating with biostatisticians to define analysis plans and statistical methods to be applied to clinical data.
• Performing quality control checks on statistical outputs and ensuring accuracy and consistency in reporting.
• Assisting in the preparation of statistical reports, presentations, and publications for regulatory submissions.
• Contributing to process improvements by identifying efficiencies in programming practices and methodologies.

Senior Statistical Programmer I

• Collaborating with statisticians and programmers to develop and validate statistical programs for clinical trial data analysis.
• Assisting in the creation of statistical analysis plans and specifications.
• Programming, testing, and documenting statistical programs in accordance with regulatory guidelines.
• Conducting quality control checks on statistical outputs to ensure accuracy and reliability.
• Supporting the preparation of data sets and statistical reports for regulatory submissions.

Junior Statistical Programmer

• Participate as a member of a working group and perform special projects, as assigned, to improve the efficiency, effective and quality of the functioning of the Development Operations department.
• Act as preliminary liaison for study sites to convey study information, answer questions and in accordance with the escalation pathway.
• Develop relationships with investigational sites, HCPs, and institutions to enhance conduct of the trial.
• Monitor study-specific timelines and key deliverables; focus on management of all relevant external vendors (e.g., Monitoring, Sample management, IVRS, Laboratory, etc.).
• Participate as a member of the multi-disciplinary trial(s) team.
• Participate in coordinating efforts with internal Pharmacovigilance, and safety group as needed.
• Participate in data review and discrepancy resolution as needed.
• Assist in the development of the IP and co-medication strategy (quantities, labels, depots, tracking, etc.) working closely with other departments.
• Plan and organize meetings with team support (e.g., investigator/coordinator meetings, DMC, SMC, safety call, etc.) as appropriate.
• Assist in the development and management of study timelines and priorities, including recruitment tools/strategy.
• Coordinate and monitor activities at investigational sites; review monitoring trip reports and support the US monitoring organization as appropriate.
• Participate in the feasibility and evaluation of investigative sites as needed, working closely with the Clinical Trial Logistics group.
• Create Master ICF template and review/approve site changes (in consultation with legal, safety when warranted).
• Update template for new risks and new amendments information.
• Assists in the review, development and writing of study documents and manuals, including but not limited to study manuals, treatment guidelines, patient access forms, laboratory or biomarker plans, and other supporting documents.

Senior Clinical Operations Lead

Clinical Research

• Assists the CS Protocol Lead and study team with the clinical/scientific conduct of clinical studies e.g., adjudication support, medical monitoring, imaging data reconciliation preparation of meeting materials, protocol deviation management
• May support a single study or multiple studies
• May lead a study with limited scope (e.g., Survival Follow-up)
• May interact with internal and external stakeholders (study sites, committees, etc.) in support of clinical study objectives

Clinical Scientist

• Managing all aspects of system requirements, system development, validation activities, ensuring smooth workflow and on-time delivery of data to customers
• Overseeing the planning, coordination, and execution of system application release schedules to meet organizational targets.
• Leading, coaching, and mentoring a team of production staff to ensure high performance and adherence to quality standards. Staff may include Technical Project Managers, Developers and Validation specialists.
• Collaborating with cross-functional teams, including Project Management, Image Operations, Data Management, Quality and Clinical Database programming
• Ensuring compliance with Standard Operating Procedures and application regulatory guidelines such as ICH and 21 CFR Part 11
• Identifying areas for process improvement and implementing initiatives to enhance productivity, reduce rework, and maintain system application quality.

Manager, Production Operations – Software Development Lifecycle

Analyst

• Coordinate and develop contracts and change orders for newly awarded and ongoing projects at ICON.
• Work simultaneously on numerous contracts and/or change orders.
• Lead discussion with ICON Legal, the Sales Team, and liaison with their respective Contracts Manager, as necessary, to determine the appropriate terms and conditions to be included in the contracts (inclusive of Start-up Agreements) and change orders.
• Understand applicable ICON costing tools, client budget grids, and any tools and templates developed within the Client Contract Services group.
• Solicit input and review of contracts and change orders from the relevant operational departments.
• Understand reasons and challenge supporting information provided by the project team related to budget changes (timeline, specifications, tasks, hours, etc.) and that the budget changes are reasonable and justified.
• Understand legal language contained in a MSA, Start-up Agreements, and standalone contracts.
• Liaise with their respective Contract Manager on any issues that need to be escalated within ICON or the client.
• Provide project/financial analysis on the project budget to justify supporting information from the project team on prior to client submission.
• Update Salesforce in a timely and consistent manner with concise, accurate information on status of the contract or change order.