ICON plc

Clinical Research

• The Senior LTM role will be accountable/responsible for ensuring top-quality end-to-end trial delivery at a country level.
• Managing the consistency of Local Trial Management duties and processes.
• The Senior LTM will serve as the country-level single point of contact on the study for internal partners.
• While the Sr LTM may delegate tasks to other LTMs or roles on the study, the Sr LTM remains accountable for successful completion of those tasks.
• The Sr LTM will manage and oversee the following throughout the study: Central IRB and other local vendors, including set up of vendor purchase orders, invoice review and approval, and change-orders, as applicable.
• Execution of local milestones from feasibility through study close out.
• Resourcing of country-level roles, including support with transitions, in collaboration and agreement with the study Functional Manager (FM).
• Inspection Readiness and AQR at the country level.
• Close collaboration with the assigned Local Trial Manager(s), Lead Site Manager, Site Managers, Clinical Trial Associates, and Site Contract Managers to outline accountabilities/responsibilities and provide support and training, where necessary.
• Efficient communication with the Clinical Trial Managers, Clinical Operations and the Global Trial Leader to oversee trial excellence.
• Country level ad hoc meetings during any phase of the study that are needed to address unexpected circumstances that might impact country or study level deliverables.
• Close partnership with the study FM to provide updates, discuss hurdles, timelines/resources, and potential risks, and assist with documentation, such as storyboards, lessons-learned, metrics, etc., that may be required by leadership.
• Autonomy with execution of local trial management services.
• Depth of knowledge with local trial management services.
• Process leadership.

Clinical Trial Manager II

Project Manager

• You will take responsibility for technical writing and documentation deliverables, applying your skills to ensure quality and efficiency.
• Coordinating project schedules, resources, equipment, and information to ensure timely completion of project tasks.
• Supporting project managers by maintaining and updating project documentation, ensuring accuracy and timely access to records.
• Communicating with cross-functional teams to provide status updates, gather information, and ensure alignment on project objectives.
• Tracking project milestones and deliverables, reporting potential delays or risks to the project manager for resolution.
• Organizing meetings, preparing agendas, and recording minutes to ensure effective communication and follow-up on action items.

Project Coordinator – Process & Systems

Analyst

• You will take responsibility for contract management deliverables, applying your skills to ensure quality and efficiency.
• Key responsibilities include: Reviewing and analyzing contracts, agreements, and legal documents related to clinical trial activities and vendor relationships.
• Negotiating contract terms and conditions with clients, vendors, and other stakeholders to ensure compliance with regulatory requirements and company policies.
• Collaborating with cross-functional teams to assess contract risks, identify opportunities for improvement, and develop strategies to mitigate potential issues.
• Maintaining accurate and up-to-date records of contract status, milestones, and deliverables using contract management systems.
• Providing guidance and support to internal teams on contract-related matters, including contract interpretation, compliance, and dispute resolution.

Clinical Trial Manager II

Project Coordinator – Process & Systems

Investigator Contracts Lead – Contract Analyst II