ICON plc

Research Scientist

• Designs and executes experiments for method development under supervision or independently depending on level
• Develops new scientific approaches to method development and communicates these to the global science team
• Depending on level the scientist may: Mentor more junior scientists and advise operation on developed methods
• Reviews and approves data of other scientists
• Provide scientific input to management and BD about new technology investments and lines of service
• Discusses scientific results with sponsors together with project manager
• Promotes ICON/PRA utilizing their scientific skills through scientific communication such as external publication of posters and journal articles.
• Perform R&D projects
• Training of technicians on technical aspects

Senior Research Scientist

Marketing

• You will direct pharmacovigilance and drug safety activities, ensuring quality, efficiency, and alignment with business objectives
• Key responsibilities include: Expand and enhance current services with a focus on innovation and introducing fresh perspectives
• Build strong client relationships to drive customer satisfaction, while maintaining high quality standards across all departmental activities through effective training, oversight, and resolution of quality issues
• Drive efficiency and productivity to maximize revenue and optimize costs, while supporting new business development and ensuring the profitability of ongoing work through effective management of change orders
• Developing and implementing comprehensive pharmacovigilance strategies that align with ICON Plc's goals and regulatory requirements
• Leading and managing pharmacovigilance teams to ensure effective safety monitoring, reporting, and compliance
• Ensuring adherence to regulatory requirements, industry standards, and best practices in pharmacovigilance
• Collaborating with cross-functional teams to support safety assessments and risk management activities
• Staying current with industry trends, regulatory changes, and emerging practices to continually improve pharmacovigilance processes and strategies
• Providing strategic leadership and guidance to enhance the overall safety profile of our products and support business objectives
• Partnering with Business Development and the rest of the ICON organization, as required, to ensure continued growth of the service area
• Partnering with clients, directly or through the management team, to understand their needs and devise and implement solutions that respond to those needs, anticipating those needs where possible
• Serving as project director for assigned projects and programs, as applicable
• Leading and present at meetings and conferences as required
• Planning and managing resources proactively and in alignment with internal guidelines and contractual obligation to maximize client’s satisfaction within the project allocated budget

Senior Director, Pharmacovigilance – Post-Marketing

Consultant

• Serve on Sponsor Standards and Technology Leadership teams.
• Consult with clients on sponsor-specific CDISC centric implementation projects.
• Participate in industry groups focused on the development of standards related initiatives (e.g. CDISC, PhUSE etc.).
• Author, maintain, implement, and report status for Standards Related Project Plans.
• Responsible for the implementation, strategy, and configuration of a metadata repository used to manage libraries of CDISC related metadata, terminology and related standards.
• Mentor Clinical Data Standards Consultants.
• Lead Subject Matter Expert teams on topics relevant to standards.
• Identify areas for process improvement which may increase productivity, quality and / or compliance of deliverables in the areas from data collections through analysis and reporting.
• Participate in the analysis of metrics and in creating recommendations to the management teams on process improvements together with the Director of Global Data Standards.

Clinical Data Standard Consultant

Manager

• Manage clinical trial operations activities, supporting your team and stakeholders to deliver high-quality outcomes across our clinical programmes.
• Focus on coordinating clinical trial management delivery, resolving issues, and developing team capability.
• Oversee the clinical portion of the budget to ensure efficient resource allocation.
• Develop monitoring plans and tools, ensuring effective study oversight.
• Train and mentor Clinical Research Associates (CRAs) to optimize their performance.
• Drive enrollment and lead study start-up activities, adhering to timelines.
• Review trip reports and implement corrective and preventative action plans when necessary.
• Foster productive relationships with Sponsors, vendors, and cross-functional teams.

Global Study Manager, Hematology

Data Scientist

• Lead DTS Development: Author and manage Data Transfer Specifications (DTS) to align external data providers and research partners on required data structures, formats, and templates.
• Oversee Data Standardization: Ensure study teams adhere to CDISC standards for external data, including biomarkers, wearable devices, IRT, imaging, and eCOA.
• Cross-Functional Collaboration: Serve as the primary contact for external data quality control, participating as an extended member of the Clinical Study Team and facilitating new test codes.
• Vendor & Process Management: Provide operational oversight to external data vendors, manage change requests for existing DTS, and contribute to continuous process improvement initiatives.
• Data Reconciliation & Compliance: Support data reconciliation, resolve structure inquiries, and comply with all regulatory requirements, including clinical protocols and analysis expectations.

Senior Lead Clinical Data Science Programmer

Research Analyst

• 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

Clinical Research Associate

Business Operations

• Managing and refreshing recurring governance and oversight reports and dashboards
• Supporting reporting cycles aligned to ILT and executive governance forums
• Ensuring data accuracy, consistency, and readiness for leadership reviews
• Scheduling and coordinating project and governance reviews
• Triaging daily incoming governance requests and issues
• Tracking actions, decisions, and follow-ups across governance forums and ad hoc inquiries
• Providing day-to-day operational support to keep governance processes running efficiently
• Preparing review materials for ILT project reviews and applicable insights to support study selections
• Coordinating cross-functional inputs to ensure review readiness
• Identifying opportunities to optimize governance and reporting processes
• Delivering actionable insights and tactical, data-driven recommendations to business leaders
• Contributes to the development of business strategies and operational plans
• Collects and analyzes data to measure performance and identify opportunities for improvement
• Identifies process or system inefficiencies, investigates root causes, and recommends practical solutions to enhance business outcomes
• Partners with stakeholders to translate business needs into clear requirements
• Supports or leads impact assessments of system or process changes and contributes to testing and implementation planning
• Prepares and/or organizes business reports, dashboards, and summaries that enable informed decision-making by business unit leaders and executives
• Collaborates with management to align on priorities and deliverables
• Supports or leads assigned initiatives, ensuring timely execution and measurable outcomes
• Provides foundational support across systems and processes, ensuring smooth operations, data integrity, and user access compliance
• Develops and distributes business communications, presentations, and training materials
• May contribute to or lead the creation of functional policies, procedures, FAQs, and user documentation
• Works cross-functionally to support or manage projects

Business Operations Specialist

• Oversee clinical data science workstreams, ensuring deliverables meet quality and timeline expectations
• Drive the analysis of clinical trial data to derive actionable insights and support decision-making processes
• Collaborate with cross-functional teams to ensure effective data collection, management, and reporting throughout clinical trials
• Oversee the implementation of best practices in data science methodologies and technologies within the organization
• Provide mentorship and guidance to junior data scientists, fostering a culture of continuous improvement
• Establish strong partnerships with internal and external stakeholders to enhance data integrity and optimize clinical outcomes

Clinical Data Science Manager

Compliance

• Contributing to regulatory strategy development for clinical programmes, including plans for health authority interactions and submissions
• Preparing, reviewing, and coordinating regulatory documents such as clinical trial applications, briefing packages, and responses to health authority questions
• Interpreting and applying relevant regulations, guidelines, and precedents to support compliant study design and execution
• Collaborating with clinical, safety, CMC, and other cross-functional teams to ensure alignment of regulatory content and messaging
• Monitoring changes in the regulatory environment and providing guidance on potential impact to programmes and submissions
• Supporting regulatory interactions and meetings, including preparation of materials and documentation of outcomes

Regulatory Scientist

Clinical Operations

• 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.

Senior Manager, Clinical Operations

Clinical Research

• Senior Local Operations Manager handling site aligned E2E partner communication across stakeholders throughout trial lifecycles
• Serve as the primary communication point for sites, facilitating client teamwork for issue resolution
• Ensure consistent conduct of site qualification visits and appropriate follow-up of site qualification visit report and country feasibility report
• Collaborate with central study team and local stakeholders for final selection of sites
• Meet recruitment targets with high quality data on time and within study budget
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the trial
• Drive study compliance by maintaining and updating trial management systems
• Contribute to site level recruitment strategy and contingency planning
• Deliver competent vendor management at the country level to support the study
• Ensure high standards for study monitoring by conducting quality local trial team meetings

Clinical Trial Manager II

• Lead the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc)
• Drive assessment, selection, engagement, and management of appropriate vendors
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and client SOPs, for all products and services delivered for their designated studies
• Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate
• Actively partner to build relationships and collaborate with oncology aligned staff in other global functions
• Encourage others within matrix and line teams to seek alternative perspectives and develop solutions
• Lead / support the conduct of investigator meetings and other study related meetings

Global Study Manager

• Manage day-to-day project and program management activities, supporting your team to deliver quality outcomes.
• 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.

• Strong ability to apply statistics in the analysis of clinical trials
• Independent leadership of the design, analysis and reporting of at least 1 complex or multiple less complex studies/projects within the Pharmaceutical/Biotechnology/Public Health setting in Industry, Government or Academia
• Demonstrated ability to provide sound strategic and statistical input on study/research design to meet project needs, regulatory and scientific requirements
• Demonstrated ability in presenting results and defending statistical findings, study design and analysis.
• Excellent oral and written English communication skills
• Authored a protocol, DRT/DMC charter, SAP, CSR, or Research Project Plan (RPP)
• Strong knowledge of current CDISC standards for ADaMs

Lead Biostatistician

Recruitment

• Focus on sourcing and hunting for talent
• Responsible for the successful sourcing of external candidates to support internal job requirements in the United States and Canada
• Develop external networks through web-based portals
• Fully utilize and maintain candidate databases and systems
• Works with the Talent Acquisition Business Partner’s to develop business and staffing requirements, recruitment strategies, and tactics
• Networking through technical journals, publications, social media and the internet
• Client mapping in order to network and build on an existing database
• Continuously sources applicants for potential openings; maintain a pipeline of qualified individuals
• Conducts screening interviews to identify qualified candidates
• Provides meaningful feedback and recommendations on candidates to the Client Facing Recruiters
• Identifies candidates for key positions, and develops the relationship required to effectively recruit for current or future positions
• Works with Talent Acquisition Business Partner’s to post open positions and publicize the role within social media forums, job boards, universities or other channels
• Engages with Hiring Managers to gain a better understanding of the recruiting needs

Senior Research Scientist

Senior Director, Pharmacovigilance – Post-Marketing

Clinical Data Standard Consultant

Global Study Manager, Hematology

Senior Lead Clinical Data Science Programmer

Clinical Research Associate

Business Operations Specialist

Clinical Data Science Manager

Regulatory Scientist

Senior Manager, Clinical Operations

Clinical Trial Manager II

Global Study Manager

Global Study Manager

Lead Biostatistician

Talent Sourcing Recruiter – Contract