ICON plc

Manager

• Work in a sponsor-dedicated model supported by ICON’s global expertise
• Manage all vendor related aspects of global clinical trials
• Plan and manage 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 relationships with trial investigators and stakeholders
• Ensure trials comply with local, national, and international regulations and ethical guidelines
• Make decisions regarding trial design, vendor selection, and risk management
• Review vendor-related protocol sections during protocol development
• Contribute to vendor contract amendments

Senior Vendor Manager

Project Manager

• Lead and manage clinical trials, ensuring successful execution and delivery of project objectives
• Manage day-to-day clinical trial project and program management activities
• Develop and execute project plans focused on achieving project goals and objectives
• Lead cross-functional teams to implement project activities
• Collaborate with stakeholders to identify project requirements and define project scope
• Mentor and guide team members
• Drive development of project documentation and reports for stakeholders
• Stay abreast of industry trends and emerging technologies to integrate best practices
• Contribute to organizational growth through project leadership and strategic planning

Senior Project Manager – General Medicine

Medical Director

• Lead medical affairs delivery across the portfolio, setting standards and developing the team
• Provide strategic medical leadership and guidance on project teams
• Offer expert medical and scientific consultation throughout project lifecycles
• Ensure compliance with ethical, legal, and regulatory standards in medical and safety monitoring activities
• Review medical data on the indication, inclusion/exclusion criteria, and other medical issues to achieve project deliverables
• Represent the Medical Affairs Department in business development initiatives, investigator meetings, and project kick-off meetings
• Provide operational oversight within the Medical Affairs Department as needed

Medical Director, Neurology

Clinical Research

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct site selection, initiation, routine monitoring, and close-out visits
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain documentation in CTMS and eTMF systems
• Support site staff training and maintain compliance records
• Monitor patient safety and ensure timely AE/SAE/PQC reporting
• Support subject recruitment and retention
• Oversee drug accountability and storage, return, or destruction
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and escalate risks or issues
• Assist with site budgets and payments
• Collaborate with CTAs, LTMs, CTMs, and other cross-functional partners

Clinical Research Associate II

• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct site selection, initiation, routine monitoring, and close-out visits
• Ensure site compliance with ICH-GCP, SOPs, and regulations
• Maintain documentation in CTMS and eTMF systems
• Support and track site staff training and compliance records
• Monitor patient safety and ensure timely AE/SAE/PQC reporting
• Support subject recruitment and retention efforts
• Oversee drug accountability and proper storage, return, or destruction
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and escalate risks or issues to the clinical team
• Assist with site budgets and timely site payments, as applicable
• Collaborate with CTAs, LTMs, CTMs, and other cross-functional partners

Principal

• Develop and maintain strong clinical trial site relationships to support a positive site/patient experience and accelerate study milestones
• Promote awareness of the sponsor’s clinical pipeline and programs to trial sites, investigators, and networks
• Conduct Monitoring Oversight Visits to assess FSP CRA monitoring quality and site inspection readiness
• Execute remote or on-site site qualification and facilitate site selection
• Schedule and conduct Site Initiation, Interim Monitoring, and Close-Out visits to co-monitor, train, and onboard FSP CRAs across oncology trials
• Review and approve FSP CRA Monitoring Visit Reports
• Review site and monitoring Key Risk Indicator metrics and contribute to the Study and Site Risk Assessment Tool
• Train and retrain FSP CRAs and sites on GCP, protocols, vendor processes, and study-specific documents
• Perform site management and act as an escalation point for FSP CRA monitoring quality issues
• Develop or ensure implementation of site CAPA Plans and escalate issues as needed
• Ensure sites are inspection-ready and support the sponsor during site inspections
• Utilize CTMS and TMF to file documents, maintain accurate site data, and audit site TMFs as needed
• Draft, review, or contribute to Site Monitoring Plans
• Contribute to monitoring process improvement initiatives, SOPs, work instructions, job aids, and tools
• Improve site selection, monitoring, and monitoring oversight templates in Veeva CTMS and EDC
• Establish relationships with investigators, site staff, sponsor study team members, and FSP CRAs

Lead CRA / Principal CRA

• Perform site management activities to support the client's Oncology site success and maintain continuous inspection readiness
• Act as the primary contact between the client's clinical trial team and sites
• Perform remote and on-site monitoring/co-monitoring visits, including Site Qualification, Site Initiation, Interim Monitoring, and Close-Out Visits
• Perform oversight activities to assess monitoring quality and train or mentor less experienced CRAs
• Document monitoring activities and submit or approve visit reports
• Manage site essential document collection and TMF reconciliation with site files
• Support local IRB/Ethics Committee submissions and confirm approvals
• Review site KRI metrics, issues, and action items to detect trends and ensure prompt resolution
• Determine root causes and develop or implement site CAPA plans
• Deliver training on protocols, SOPs, GCPs, and regulations
• Support sites and the client's regulatory inspections
• Contribute to site identification, feasibility, qualification, and activation activities
• Lead site engagement initiatives and foster relationships with Oncology sites and networks

Senior Clinical Research Associate

• Perform site management activities to support the client's Oncology site success and maintain inspection readiness
• Act as the primary contact between the client's clinical trial team and sites
• Perform remote and on-site monitoring/co-monitoring visits, including qualification, initiation, interim monitoring, and close-out visits
• Perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
• Document monitoring activities and submit/approve visit reports
• Manage site essential document collection and TMF reconciliation
• Support local IRB/Ethics Committee submissions and confirm approvals
• Review site KRI metrics, issues, and action items to detect trends and ensure resolution
• Determine root causes and develop/implement site CAPA plans
• Deliver training on protocols, SOPs, GCPs, and regulations
• Support sites and the client's regulatory inspections
• Contribute to site identification, feasibility, qualification, and activation
• Lead site engagement initiatives and foster relationships with Oncology sites and networks

Director

• Lead, provide guidance and delegate appropriately to a cross-functional study team or oversee outsourced delivery activities
• Ensure clinical studies progress as planned and achieve milestones according to timelines, budget, and quality standards
• Lead and facilitate communication across functions, external partners, and service providers
• Lead and conduct investigator meetings and other study-related meetings
• Provide input into and hold accountability for essential study-level documents from Clinical Study Protocol through Clinical Study Report
• Develop and maintain study plans, quality and risk management plans, risk response strategies, and issue escalation pathways
• Oversee external service providers, including CROs, central laboratories, IXRS, and ePRO vendors
• Identify and report study quality issues and communicate corrective action plans
• Oversee Trial Master File completion and ongoing quality-control activities
• Ensure compliance with governance controls, including Delegation of Authority, Sunshine Act, financial attestations, and Clinical Trial Transparency
• Re-forecast and manage study budgets and provide budget progress reports and mitigation plans
• Ensure studies remain inspection-ready under ICH-GCP, SOPs, and relevant policies and serve as primary Study Management contact during audits or inspections
• Provide performance feedback and mentor less experienced colleagues

Global Study Associate Director

• Manage day-to-day clinical trial management activities
• 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 relationships with trial investigators and stakeholders
• Ensure trials comply with local, national, and international regulations and ethical guidelines
• Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management
• Support the team and stakeholders to deliver high-quality outcomes across clinical programmes

Clinical Trial Manager

• Manage day-to-day clinical trial management activities, supporting the team to deliver quality outcomes
• 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 relationships with trial investigators and stakeholders
• Ensure trials comply with local, national, and international regulations and ethical guidelines
• Problem-solve and make critical decisions regarding trial design, vendor selection, and risk management

General

• Support the management of clinical trial sites by assisting with site monitoring activities
• Ensure compliance with study protocols and maintain high standards of operational efficiency
• Assist in monitoring clinical trial sites for adherence to study protocols, regulatory requirements, and Good Clinical Practice (GCP) guidelines
• Support site management activities, including documentation preparation, data entry, and tracking site performance metrics
• Collaborate with cross-functional teams to facilitate communication and address site-related issues
• Maintain accurate records of site activities and contribute to monitoring reports
• Participate in training and development initiatives

Study Delivery Specialist

• Draft and negotiate work order agreements, change order amendments, loan equipment agreements, non-disclosure agreements, and requests for proposals
• Review, revise, and manage contracts supporting consulting, supplier, distributor, clinical, service, and other non-standard agreements
• Escalate complex legal and factual matters to Legal and support issue resolution
• Oversee contract lifecycle management, including maintaining contract files, managing the contract request system, tracking deliverables, and generating reports
• Partner with business teams to prepare and execute CDA and NDA agreements
• Lead onboarding and training for new Contract Managers
• Train internal stakeholders on contract management systems and processes
• Facilitate weekly and monthly contract status meetings as appropriate
• Prepare contract summaries and ensure agreements are executed in compliance with company policies and service level standard turnaround times
• Support business contract requests and monitor execution timelines
• Secure required internal approvals for contract terms and provisions prior to execution
• Identify and implement process improvements to enhance efficiency and ensure compliance with internal policies and external regulations

Manager, Contracts and Budgets

Associate

• Lead the initiation of clinical trials, ensuring compliance with regulatory requirements
• Contribute to site start-up and activation activities and take responsibility for deliverables
• Prepare and submit regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
• Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
• Manage and maintain records of regulatory submissions, approvals, and correspondence
• Provide guidance and support to study teams on regulatory requirements and study start-up best practices
• Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency
• Collaborate with cross-functional teams

Study Start Up Associate II

• Assist in the coordination and administration of clinical trials, ensuring compliance with protocols and regulatory requirements.
• Maintain and organize clinical trial documentation, including study files, essential documents, and regulatory submissions.
• Support the preparation of study-related materials, such as informed consent forms and case report forms.
• Work with cross-functional teams to facilitate communication and ensure smooth trial execution.
• Contribute to the tracking and reporting of clinical trial metrics and milestones.
• Assist with the design and analysis of clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.

Senior Vendor Manager

Senior Project Manager – General Medicine

Medical Director, Neurology

Clinical Research Associate II

Clinical Research Associate II

Lead CRA / Principal CRA

Senior Clinical Research Associate

Senior Clinical Research Associate

Global Study Associate Director

Clinical Trial Manager

Clinical Trial Manager

Study Delivery Specialist

Manager, Contracts and Budgets

Study Start Up Associate II

Clinical Trials Associate