ICON plc

Manager

• Assist the SM Study Lead and study team with the operational conduct of clinical studies (e.g., CTT minutes, clinical supplies planning/tracking, lab specimen tracking, imaging data reconciliation, status update reports, study closeout activities)
• May support a single study or multiple studies
• May lead a study with limited scope (e.g., Survival Follow-up)
• May be responsible for tracking study timelines and will be proficient in project management tools
• May interact with internal and external stakeholders (study sites, vendors, committees, etc.) in support of clinical study objectives

Study Manager – COPD, OPTAL

Software Engineer

• Analyze clinical trial data and support the statistical analysis process to ensure high-quality results.
• Lead on statistical programming tasks requiring technical depth, with a focus on quality and continuous improvement.
• Develop and validate SAS programs for statistical analysis and reporting of clinical trial data.
• Collaborate with biostatisticians to define analysis plans and statistical methods to be applied to clinical data.
• Perform quality control checks on statistical outputs and ensure accuracy and consistency in reporting.
• Assist in the preparation of statistical reports, presentations, and publications for regulatory submissions.
• Contribute to process improvements by identifying efficiencies in programming practices and methodologies.

Senior Statistical Programmer

Research Analyst

• Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness
• Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites
• Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials
• May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
• Promptly document monitoring activities and submit/approve visit reports
• Manage site essential document collection and TMF reconciliation with site files
• Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals
• Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution
• Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans
• Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
• Support sites and the client's regulatory inspections
• Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities
• Lead site engagement initiatives and foster relationships with key Oncology sites and networks

Senior Clinical Research Associate

• You will contribute to clinical trial monitoring activities, taking responsibility for your deliverables and working collaboratively.
• 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

Content Writer

• Lead a team of medical writers to produce high-quality, scientifically accurate documents in support of clinical trials.
• Manage the medical writing team, providing guidance and oversight to ensure high-quality, consistent, and scientifically sound documentation.
• Oversee the preparation of clinical study reports, regulatory submissions, protocols, investigator brochures, and other key clinical documents.
• Collaborate closely with cross-functional teams including clinical, regulatory, and project management teams to ensure alignment and accuracy in documentation.
• Ensure all documents comply with applicable regulatory guidelines and internal standards while maintaining clear and concise scientific communication.
• Track project timelines and deliverables, ensuring all documentation is completed and submitted within established deadlines.
• Continuously improve writing processes and templates, incorporating best practices to enhance the efficiency and quality of the medical writing function.

Manager, Medical Writing

Data Analyst

• Support Trial Operations data governance by performing manual stewardship review for the Trial Ops MDM domain.
• Partner with Trial Ops Governance, Data Owners/Stewards, and operational stakeholders.
• Improve and sustain data quality and integrity for Trial Ops master data.
• Perform manual review and validation of Trial Ops MDM records against defined standards.
• Triage, investigate, and resolve basic data quality issues and route complex exceptions.
• Execute stewardship workflows in the designated tools ensuring requests are processed within agreed SLAs.
• Document decisions and rationale for approvals/rejections/holds in alignment with Takeda governance practices.
• Apply data governance policies and ensure adherence to Takeda Quality Management System.
• Monitor and report on operational metrics, escalating emerging risks and proposing remediation steps.
• Support data cleansing and remediation activities under the direction of the domain steward/governance lead.
• Coordinate with cross-functional teams to clarify requests and prevent recurring data issues.
• Contribute to continuous improvement by identifying opportunities to streamline manual review steps.

Trial Operations Data Analyst

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.
• They are site aligned E2E partner to streamline communication across cross functional stakeholders throughout trial lifecycles.
• Serves as the primary point of communication for sites, facilitating internal client teaming to drive issue resolution.
• Intimately understands site operational model and owns relationships with critical site stakeholders to provide a voice for the site to the client's teams.
• Principal Local Operations Manager: trial aligned member of CFTT for USA-level accountability, serves as “quarterback” for Local Operations Managers and representing a single voice to the global team.
• The Sr LTM will manage and oversee the following throughout the study: Central IRB and other local vendors.
• 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) (LTMs), Lead Site Manager (LSM), Site Managers (SMs), Clinical Trial Associates (CTAs), and Site Contract Managers (SCMs) to outline accountabilities/responsibilities and provide support and training, where necessary.
• Efficient communication with the Clinical Trial Managers (CTMs), Clinical Operations and the Global Trial Leader (GTL) 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 that may be required by leadership.
• Autonomy with execution of local trial management services.
• Depth of knowledge with local trial management services.

Senior Clinical Trial Manager

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

• Read and understand protocol-specific design, objectives, and study procedures
• Prepare study-specific informed consent documents using established templates, information from protocols, content libraries and glossaries (when appropriate), and required risk language
• Work with protocol authors to ensure comprehensive understanding of protocol details and the protocol approval timeline
• Write, edit and review informed consent documents that reflect the principles of health literacy
• Manage informed consent writing projects including the design, planning, and preparation of documentation in support of clinical development
• Participate, when appropriate, in clinical trial team meetings to ensure timely delivery of the informed consent document(s)
• Resolve document issues relating to informed consent
• Support Global Clinical Trial Operations with informed consent process expertise and study specific support
• Possible participation in the orientation and coaching of junior team members
• Possible participation in initiatives to improve medical writing processes and standards
• Support tool development, enhancements, and testing, as applicable
• Ensure compliance with company training and time reporting

Informed Consent Writer

Data Engineer

• Design and implement enterprise-grade data architectures, including data lakes, warehouses, and integration layers.
• Build and maintain automated data pipelines for ingesting, validating, transforming, and storing data from multiple sources.
• Develop scalable data models and schemas to support consistent metrics, reporting, and analytics.
• Establish and apply data standards and quality controls to ensure accuracy, reliability, and repeatability.
• Collaborate with stakeholders to understand data and reporting requirements and translate them into technical solutions.
• Partner with analytics and visualization teams to ensure data is well-structured and optimized for downstream use.

Data Engineer, Architect

• 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.

Contract Analyst II

Clinical Research Associate II – Senior Clinical Research Associate

• 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.

Global Study Manager

Project Manager

• Build relationships both internally and externally, driving IRT activities across multiple studies to stay within timeline and budget.
• Facilitate meetings, manage timelines, provide input into requirement designs, control budget, proactively communicate to key stakeholders including sponsors, identify risks, create appropriate action plans, and provide detailed oversight of all activities such as data changes and system updates during the maintenance phase.
• Assess and communicate effectively with clients while balancing multiple priorities.

Project Manager, IRT

• Provides scientific, technical and regulatory support to projects that have significant Pharmaceutical Supply Management, Chemistry, Manufacturing and Control (CMC) activities associated with them.
• Acts as the lead on appropriate project teams.
• Manages global pharmaceutical supply for all phases and pharmaceutical development activities ongoing at contract facilities with respect to technical, quality, timing and cost standpoint on behalf of clients.
• Oversees labelling, packaging and distribution activities of CMO including review and approval of labelling / packaging records and distribution plans.
• Oversees recall, returns and destruction activities, as appropriate.
• Oversees the procurement of marketed drug product, such as comparators performed by an approved vendor and ensuring that all study specific regulatory requirements are met.
• Performs Batch Record Review and Approval, as applicable.
• Manages temperature deviation, product complaints and recalls, as delegated by the client.
• Conducts gap analysis of processes relating to pharmaceutical supplies for applicable project teams.
• Participates in discussions of objectives and scope of prospective projects with potential clients.
• Maintains confidentiality of management information as appropriate.
• Liaises with other managers to improve the effectiveness of the organisation.
• Undertakes other reasonably related duties as may be assigned from time to time.
• Travel (approximately 10%) domestic and/or international.