ICON plc

Clinical Research

• 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.

Senior Clinical Trial Manager – Internal Medicine

Clinical Operations

• Leading the operational planning and execution of clinical trials, ensuring adherence to protocols and timelines.
• Engaging with cross-functional teams to optimize trial design and enhance operational efficiency throughout the clinical development process.
• Monitoring trial progress and performance metrics, providing insights to inform decision-making and drive continuous improvement.
• Mentoring and developing junior staff, fostering a culture of collaboration and excellence within the team.
• Building strong relationships with internal and external stakeholders to facilitate smooth communication across clinical operations.

Manager, Clinical Operations

Data Scientist

• Develop, validate, and maintain programming solutions for CDMS (EDC systems such as Rave and Veeva), data validation/analytic outputs, data review/risk management outputs, custom reports, and programs in clinical trials
• Develop and maintain programs required for handling external vendor data
• Perform extracts of data from CDMS and create data transfer programs
• Collaborate with data managers, project managers, and biostatisticians, among other positions, to ensure the integration of programming solutions into the overall data management process
• Act as a primary point of contact during the study set up and maintenance phase for system programming related questions by the project team
• Actively participate in internal and external meetings and provide constructive feedback to peers, team leads, and functional management.
• Act as mentor and provide ad hoc guidance, training, and support to other programmers
• Support knowledge sharing within the Programmers group through presentations and preparation of training materials.
• Assist in the development and implementation of improvements to technical systems and processes within an SME role
• Stay updated on advancements in programming languages and data management tools to enhance operational efficiencies

Principal Clinical Data Science Programmer

• Leading the design and execution of clinical studies, ensuring adherence to protocol and regulatory requirements.
• Collaborating with cross-functional teams to develop study protocols, informed consent forms, and study reports.
• Analyzing clinical data and interpreting results to support decision-making and regulatory submissions.
• Providing scientific input and strategic guidance throughout the clinical development process.
• Establishing partnerships with key stakeholders to ensure alignment on study objectives and outcomes.

Clinical Scientist II

QA Engineer

• Leading the development and implementation of quality assurance strategies and processes to support clinical trial activities.
• Conducting comprehensive quality assessments and audits to ensure compliance with regulatory standards and guidelines.
• Collaborating with cross-functional teams to identify and address quality issues and implement corrective actions as needed.
• Providing expert guidance and support to staff regarding quality assurance policies, procedures, and best practices.
• Contributing to the continuous improvement of quality management systems and documentation.

Director, Quality Assurance

• Leading the design and implementation of data science strategies to enhance clinical trial data analysis.
• Collaborating with cross-functional teams to identify key data requirements and analytical needs.
• Overseeing the development of statistical models and analytical tools to optimize data interpretation.
• Mentoring and guiding team members in best practices for data analysis and visualization.
• Communicating findings and insights to stakeholders through presentations and reports, influencing project direction.

Clinical Data Science Lead

Analyst

• Collaborate with internal stakeholders to review, draft, and negotiate contracts for clinical research projects, ensuring alignment with regulatory requirements and company policies.
• Conduct thorough analysis of contract terms, conditions, and obligations to identify risks, opportunities, and areas for improvement.
• Provide guidance and support to project teams on contract interpretation, compliance issues, and contractual rights and obligations.
• Maintain accurate and organized contract records, tracking key milestones, deliverables, and deadlines.
• Assist in the development and implementation of contract management processes, procedures, and best practices to optimize efficiency and mitigate risks.

Senior Contract Analyst

Compliance

• Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA EU CTR and UK-specific submissions essential experience here required
• Management of activities associated with obtaining initial, amendment and other central authority approvals
• Companion diagnostics, IVDR submissions, clinical performance studies experience would be beneficial
• Oversee preparation of core regulatory packs.
• Provide broad regulatory support across EU and UK requirements.
• Provide regulatory guidance and efforts to internal teams
• Participate in agency interactions and regulatory submissions
• Contribute to developing best practices within ICON Regulatory Affairs through your insight of regulatory processes and guidelines
• Work collaboratively as part of a regulatory or cross-functional team, depending on project size and nature

Regulatory Submissions Manager – EU CTR

Risk

• Facilitate trial protocol risk assessment across multiple cross-functional domains (clinical, operational, data management, vendors, regulatory etc.) associated to critical-to-quality (CtQ) data and processes, including definition of quality tolerance limits (QTLs), evaluation of risks based on likelihood, detectability, impact, and ensures mitigation strategy / plans are defined
• Responsible for drafting, maintaining, and archiving the study specific documentation of risk management activities
• Partners with the RBQM system configuration team to ensure risk indicators, quality tolerance limits and other analytics/visualizations are programmed and functioning per operational requirements in the RBQM system
• Conduct of periodic central surveillance of the aggregate data at the study and program level, leveraging available analytics/visualizations in the RBQM system, to identify emerging risks and/or issues
• Facilitate risk review meetings and discussions with study / program team members to effectively communicate and discuss the findings, support, and encourage robust root cause identification and mitigation strategies
• Supports and participates in internal and external audits and inspection
• Collaborate with training departments to support training initiatives and aid in the adoption of the RBQM approach.

Risk Surveillance Lead

• 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.

Governance Quality Operations Lead

Research Analyst

• Monitoring clinical trial sites to ensure adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) standards.
• Conducting site visits to assess site performance, resolve issues, and provide support to ensure successful trial execution.
• Collaborating with cross-functional teams to ensure timely and accurate data collection and reporting.
• Providing training and guidance to site staff and other CRAs to maintain high standards of clinical trial conduct.
• Building and maintaining effective relationships with site personnel and stakeholders to facilitate smooth trial operations.

Senior Clinical Research Associate – FSP

Support Engineer

• Recognize, exemplify and adhere to ICON's values
• Monitors and validates the addition of new lab-specific test units and ranges
• Instructs Result Entry team regarding required changes
• Identify discrepancies on Laboratory reports and troubleshoot
• Manages client issue research and resolution
• Performs quality checks on reference ranges and test codes
• Releases data/results and maintains laboratory accreditations

Senior Technical Analyst

Director

• Responsible for oversight and maintenance of study timelines and activities.
• Responsible for the operational and commercial delivery of business targets.
• Tracking and maintaining laboratory activity metrics and reporting to management.
• Maintenance of Laboratory Accreditation and Quality Standards.
• Scientific management of the LC-MS services section.
• Work closely with the management team to gain repeat business and meet budget targets.
• Maintain good communication between service groups.

Director, Bioanalytical Services

Procurement

• Act as a single point of contact between Accellacare, Alliance Partner, and the Sponsor to drive the successful development and implementation of site support specialists, report key metrics, and resolve challenges as they arise
• Provide strategic oversight of Site Support Resourcing, monitor Site Support Leads, and CTAs Specialist progress and ensure tasks are completed in a timely manner
• Ensure appropriate legal agreements are in place for project execution
• Lead planning of staff deployment including, training, startup, sponsor interactions, and close out
• Lead strategy related discussions with Sponsor, including contract deliverables, budget allocation, and performance metrics
• Drive process improvement, efficiencies and technological development to meet KPIs and delight customers, sites, and team members
• Work in an integrated model within the study team, liaising with Oversight Manager, PD, PM, CTLs, SELs and CTM
• Ensure country regulations are followed per SOW
• Understand assigned protocol and lead creation/coordination of quality and quantity of ROI
• Provide feedback to management on the effectiveness of the activities for each project
• Ensure study materials are saved and filed appropriately to ensure 100% compliance
• Financial oversight including unit trackers, invoices, and follow-up to sponsors and sites, budgeted vs. actuals, and reporting to clients and forecasting
• Work along with Strategic Partners for staff allocation for specific assignments
• Provide Project Management and People Leader Oversight for all aspects of contracted projects
• Responsible for full rollout and training on the official ASR work model to include KPI development, conflict of interest management, case study development, ethics oversight, and compliance of new processes
• Revenue tracking, management of full-service studies, frequent forecast changes, and metrics reporting

Manager, Site Resourcing

Human Resources

• Owning and executing the product strategy and roadmap for the Workday platform, aligning priorities with business objectives and enterprise HR technology strategy
• Partnering with senior HR and IT stakeholders to identify opportunities where Workday capabilities can address business challenges and enhance the employee and manager experience
• Leading cross-functional teams (HR, IT, vendors, and delivery partners) to design, develop, and launch new Workday functionality and enhancements
• Translating business needs into clear product requirements, epics, and roadmaps while managing trade-offs across scope, timeline, and resources
• Ensuring SOX compliance, data integrity, and adherence to IT Change Control processes across all Workday-related initiatives
• Driving and supporting business cases to secure funding for Workday and HR technology programs
• Providing strategic recommendations on new technologies, Workday features, and integrations to improve platform effectiveness and scalability
• Supporting acquisition activity by ensuring newly acquired companies are efficiently and effectively integrated into the Workday ecosystem
• Managing and prioritizing product backlogs and demand, ensuring work is sequenced in line with stakeholder objectives and resource capacity
• Mentoring and guiding product and HR technology team members, fostering a culture of ownership, innovation, and continuous improvement
• Staying current on Workday releases, industry trends, and emerging HR technologies to inform product strategy and roadmap decisions