ICON plc

Compliance

• Lead regulatory submissions that enable trials to start on time – Prepare and submit clinical trial applications, ethics committee submissions, and communications with regulatory authorities, ensuring every study begins with the highest standards of compliance and integrity.
• Coordinate across teams and stakeholders to unlock study progress – Liaise with internal colleagues and external partners to secure approvals and authorizations, keeping studies on track and supporting patient access to innovative treatments.
• Ensure transparency and accuracy in all regulatory records – Maintain comprehensive documentation of submissions, approvals, and correspondence so that study decisions are informed, traceable, and compliant with global and local regulations.
• Empower study teams with regulatory expertise – Provide guidance and support on study start-up requirements, helping colleagues navigate complex regulatory processes efficiently and effectively.
• Drive process improvements that accelerate research – Identify opportunities to optimize start-up workflows, enhancing efficiency and contributing to ICON’s culture of quality and innovation.

Study Start Up Associate II – Regulatory

Manager

• Serve as scientific expert and pharmacovigilance resource to external and internal partners within the region.
• Assess current processes to ensure adherence to applicable regulatory requirements and, where needed, enhance and/or develop new processes while assuring consistency with client standards.
• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the harmonization of processes across the regions.
• Liaise between the global functions, the affiliates and Business Partners (overall Territories: EU, Canada, Australia, US, Japan and Brazil, MENA, South Korea, China, Singapore)
• Support the Head of Regional PV and EU/UK QPPV and the Regional PV Leads in the management of innovation projects for increasing Regional Team efficiency.
• Support the Regional PV Leads in the establishment and maintenance of the applicable pharmacovigilance system specific to the country/region
• Support the Regional PV Leads in the revision of documents pertinent to Regional PV tasks
• Promote increased awareness of and ensure compliance with pharmacovigilance obligations for the country/region.
• Contribute to the Pharmacovigilance System Master File (PSMF) data collection in any applicable country/region
• Contribute to increase the visibility of the GPS team/function throughout.
• Closely collaborate with other functions including regulatory, marketing, medical, communications, quality, legal, as well as other teams as needed.
• Develop relationships with cross functional teams as it relates to adverse event reporting and other pharmacovigilance activities.
• Maintain an in-depth knowledge of local regulations, expectations and regulatory authority contacts and perform activities related to the interpretation and review of existing and evolving safety requirements.
• Actively participate in GPS audit and inspection readiness, support, and management together with the GPS Quality Management team and the Quality team.
• Maintain knowledge of the Company product portfolio and disease areas for marketed drugs and drugs in development.
• Contribute to the development and evaluation of Key Performance Indicators as related to pharmacovigilance as it relates to the assigned tasks.
• Drive Continuous Improvement initiatives as needed.
• May perform other tasks as appropriate.

Senior Regional Pharmacovigilance Manager

• Lead regulatory activities and submissions independently, with prior experience in areas such as CTA/IND/MAA
• 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

• Plan and manage all aspects of clinical trials, ensuring adherence to timelines, budget, and quality standards.
• Collaborate with cross-functional teams to establish and implement clinical trial protocols and procedures.
• Build and manage strong relationships with trial investigators and stakeholders.
• Ensure all trials are conducted in compliance with local, national, and international regulations and ethical guidelines.
• Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management.
• Review of vendor related protocol sections during protocol development
• Contribute to the development of vendor contract amendments

Senior Vendor Manager – 6 Months Assignment

Project Manager

• Responsible for the overall tactical and strategic direction and management of projects through designated project managers, ensuring consistency with corporate strategy, consistency of process across projects and internal and external customer satisfaction with the projects.
• Directs and provides day-to-day tactical oversight to their assigned Project Management team.
• Provides vision, leadership and mentorship to assigned team with respect to performance and career development.
• Accountable for the overall direction, coordination, implementation, execution, control and completion of all programs/projects, ensuring consistency with company strategy, commitments and goals.
• Accountable for compliance of the Project Management team with IMC and ICON policies and procedures.
• Ensure optimal planning, allocation and performance of resources within Project Management.

Senior Manager, Project Management – Imaging and Cardiac

• The Senior Project Manager is the main point of contact for customers on all assigned projects and acts as the lead on a portfolio of clinical trials within ICON Medical Imaging and Cardiac Safety Solutions team.
• Act as primary point of contact for customer communication, managing routine teleconferences and reporting deliverables.
• Responsible for developing project timelines, assure adherence to the timelines, and provide customer support throughout the life cycle of a project for all study-related activities within a clinical trial.
• Coordinate cross-functional activities of internal resources to ensure quality and on-time project deliverables are met.
• Responsible for maintaining the proper project documentation and ensuring compliance with SOPs and regulatory requirements for clinical trials.
• Responsible for revenue forecasting, tracking, and submittal, and will also update budgets and contracts as necessary.

Senior Project Manager, Imaging and Cardiac

Therapist

• 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 CTM – Cell Therapy

Risk

• Developing and implementing 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.
• Participating in the review and approval of clinical trial documentation and data to ensure accuracy and completeness.
• Providing leadership and mentorship to quality assurance staff, fostering a culture of excellence and continuous improvement.

Governance Quality Operations Lead

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 – Sponsor Dedicated

• Provide end-to-end oversight of the Trial Master File (internally and externally managed eTMF).
• Serve as the eTMF business owner.
• Ensure TMF completeness, accuracy, and timeliness in accordance with ICH-GCP, regulatory requirements, and internal SOPs.
• Lead TMF quality review activities, including periodic QC, reconciliation, and ongoing completeness checks.
• Ensure TMF inspection readiness and support internal, sponsor, and regulatory inspections and audits.
• Manage and optimize TMF-related processes, standards, and SOPs.
• Author and review clinical trial documentation, including TMF Management Plans, content list, study related plans, process documentation, training materials, etc.
• Serve as a subject matter expert (SME) for the eTMF system, including configuration, taxonomy, metadata, and user adoption.
• Develops requirements for reporting from the system, participate in UAT test script generation, UAT testing, and quarterly system update release review and approval.
• Manage continuous improvement initiatives to enhance TMF quality, efficiency, and compliance.
• Support TMF migrations, system upgrades, and vendor transitions as needed.
• Partner with Clinical Operations, Clinical Trial Managers, Quality Assurance, cross functional members of the Clinical Sub-Team (CST) and external vendors to ensure TMF alignment and compliance.
• Provide TMF guidance and training to internal teams and study partners.
• Act as the primary TMF point of contact for assigned studies.
• Manage CRO partners on eTMF-related activities.
• Lead or mentor TMF managers, specialists, or vendors as applicable.
• Contribute to TMF strategy, governance models, and global standards.
• Support TMF-related risk assessments and mitigation plans.

Manager, TMF

• Developing and executing comprehensive patient recruitment strategies tailored to specific clinical trial objectives, ensuring alignment with study protocols and timelines.
• Leading cross-functional teams in the identification and engagement of target patient populations, utilizing data-driven insights to optimize recruitment efforts.
• Building and maintaining partnerships with healthcare providers, patient advocacy groups, and community organizations to enhance recruitment and retention strategies.
• Analyzing recruitment metrics and performance data to identify trends, challenges, and opportunities, making data-informed recommendations for improvement.
• Creating and overseeing the development of patient-centric marketing materials and outreach campaigns to effectively communicate trial benefits and address patient concerns.
• Providing training and guidance to project teams and staff on recruitment best practices, tools, and techniques to enhance recruitment success.
• Staying informed about industry trends, regulatory guidelines, and emerging technologies that impact patient recruitment and engagement.
• Monitoring recruitment progress and outcomes, reporting on successes and challenges to senior leadership and stakeholders.

Patient Engagement Manager

Analyst

• Execute and ensure the effective execution of work plans resulting in the development of relevant, reliable, and timely evidence for patients, regulators, clinicians, caregivers, and payers.
• Design and execution of research to inform COA strategy development.
• Develop and execute psychometric analysis strategy.
• Support clinical trial development for assigned programs, including relevant portions of protocols, statistical analysis plans, study reports, briefing books, and related documents.
• Identify gaps in available evidence needed to support fit-for-purpose use of COAs in a specified context.
• As needed, design and execute research to develop or modify COA instruments for inclusion in assigned programs.
• Consult on COA regulatory strategy.
• Create and oversee the creation of scientific materials that are submitted to regulators ensuring consistent quality.
• Develop publications of early COA research for disclosure in peer-reviewed journals and at scientific meetings.
• Ensure effective packaging of information and scientific materials for patients and caregivers for dissemination and disclosure.
• Develop effective working partnership with project management teams which enable teams to deliver planned work.
• Ensure regular and transparent communication of project status to team members.
• Ensure that appropriate measures and metrics are in place.

Clinical Outcomes Assessment Analyst

Clinical Research

• Lead and manage the planning, execution, and monitoring of single service projects within the Accellacare program, ensuring adherence to project timelines, budgets, and quality standards
• Define project scope, goals, deliverables, and resource requirements
• Develop detailed project plans, timelines, and risk mitigation strategies
• Assemble, coordinate, and support project teams to ensure successful delivery
• Monitor project progress, quality, and budget using appropriate tools
• Communicate regularly with stakeholders through progress reports and updates, and collaborate with cross-functional teams to identify and address project risks and issues
• Manage project changes, conduct evaluations, and assess final outcomes

Clinical Research Site Project Manager

Data Scientist

• Develop and oversee timeliness of clinical data science activities during the life cycle of studies as it relates to data review and data delivery milestones
• Provide input into clinical system development activities and clinical risk management activities
• Track and keep functional management and those responsible for project management informed of any issues that might affect project target dates, scope or budget and escalates potential problems effectively and in a timely manner
• Forecast budget, hours, and resourcing for clinical data review activities
• Perform analytic review as defined in the scope of work and functional plans focusing on errors that matter or have a meaningful impact on the safety of the subject or interpretation of the final analysis
• Accountable for the development of planning documents related to data review, data analytics, and data deliverables.
• Participate in Sponsor and/or third-party audits.
• Negotiate timelines and key deliverables with clients and/or external customers, vendors, and departments as needed
• Travel (approximately 15%) domestic and/or international

Senior Clinical Data Science Lead

Affiliate Manager

• Accountable for site start-up and activation
• Deploy GSSO site strategies by qualifying and activating assigned sites
• Supports processes to optimize country & site selection activities including review and assessment of the draft potential site list & provide PTA output for site selection.
• Collaborate with key stakeholders providing country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices (as applicable) under supervision.
• Maintain a thorough knowledge of assigned protocols
• Conduct study start up activities at the site level including but not limited to PTA, coordination of site activation checklist items, ICD finalization, SIV (as applicable), including management of issues that may compromise time to site activation.
• Ensure all the site initiation activity including training per site activation checklist, collect and complete necessary documentation/ systems needed for site activation.
• Support country specific ICD review and deployment when applicable
• Ensure follow up activities completion post PTA and SIV to ensure site readiness for FSFV
• Partners with site monitor to ensure site monitoring readiness in anticipation of first subject first visit
• Responsible for relationship building and operational oversight of the site
• Provide study support on escalated site issues related to study delivery by coordinating communications and resolution efforts.
• Ensure the strategy/approach for IP and ancillary supplies for sites and country requirement throughout the lifecycle of the study
• Be accountable for effective site recruitment planning and delivery, consistent with global and/or country plan and local targets; Responsible for enrollment support and ensure progress by responding to recruitment issues from investigators.
• Maintain regular communications with investigator sites to gather status updates and drive delivery to study goals e.g. recruitment, data entry timelines etc).
• Partner with local RA/ CTRO / SAP to ensure timely completion on country / local registry when applicable
• Accountable for study conduct and close-out
• Act as operational point of contact for all site-level questions, liaising with and escalating to appropriate teams to respond and resolve questions.
• Review Site Monitoring Reports
• Support the site with revision and submission of ICD documents (and amendments).
• Working with other roles, maintain system management (e.g., EDC , Shared Investigator Platform, Site Profile and other systems as applicable) at site level ensuring alignment across platforms.
• During the conduct of the study, the Site Management Organization Assessment is reviewed with the site, when applicable, on an annual basis following site initiation and updated as needed under DCSO/ Senior SCP supervision.
• Review and manage site practices that differ from sponsor practices and liaise with study management and Business Process Owners as needed.
• Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
• Oversight and management of site deliverables to study targets, i.e. data cuts/sweeps, interim analyses, database locks, helping to oversee data is up to date and any other site-facing deliverables, i.e. investigator signatures.
• Follow the study oversight plan and proactively put in place mitigations for known/anticipated risks.
• Support development and delivery including issue resolution of decentralized capabilities at investigator sites e.g. home health, ePRO, DTP etc.
• Assure quality and consistency in the delivery of monitoring
• Drive monitoring efficiencies and best practices for study/region/program
• Support shaping the local clinical development environment with a goal to enhance sponsor reputation in scientific leadership.
• May act as a Subject Matter Expert on sponsor systems and processes.
• Actively pursue possible efficiencies and develop best practices in the delivery of activities for site performance throughout the life cycle to increase investigator/site satisfaction and strengthen site relationships
• Ensures clear and open communication with Study Operations Manager
• Support the site monitor to develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Country Trials Manager and Study Management.
• Provide input into site recommendations via intimate understanding of country/region, sites, processes and practices, and associated site performance metrics.
• Provide support to the Study Operations Manager/Global Study Manager to define local requirements for the importation/exportation processes of the investigational medical product and ancillary supplies.