ICON plc

Project Manager

• Accountable for the global study delivery strategy (e.g., country selection, diversity, patient engagement strategy, recruitment plan, etc.) and for overall study deliverables
• Drive assessment, selection, engagement, management, and oversight of appropriate vendors
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and sponsor SOPs, for all products and services delivered for their designated studies
• Make decisions which balance risk/benefit with clear understanding of impact on the study and project; takes action to mitigate risk where appropriate
• Work with matrix partners, asset lead and/or manager to develop and manage study level budget within project allocation
• Preparation of materials for governance and / or financial review cycles and provide expert clinical operational input into protocol development
• Lead and conduct investigator meetings and other study related meetings and participate in governance meetings as necessary
• Identify and communicate resource gaps for assigned studies
• Lead risk management and quality efforts to ensure study compliance and continual inspection readiness
• Lead / contribute to ways of working and process improvement initiatives
• Encourage others within matrix and line teams to seek alternative perspectives and develop solutions
• Partner with Data Management and Clinical Sciences to develop the data cleaning strategy for the study and collaborate with Oncology aligned staff in global functions to deliver the Clinical Study Report
• Work with the Oncology patient councils to develop patient centric documents and address patient burden

Research Analyst

• Delivering clinical trial monitoring work to a high standard
• Working closely with team and stakeholders
• Coordinating all activities for setting up and monitoring a study
• Completing accurate study status reports and maintaining study documentation
• Running sponsor generated queries efficiently and taking responsibility for study cost efficiency
• Participating in the preparation and review of study documentation and feasibility studies for new proposals as required
• Developing and maintaining strong, collaborative relationships with key stakeholders, clinical investigators, and site staff
• Ensuring patient safety by ensuring compliance with ICON's procedures, protocols, and regulatory requirements

Clinical Research Associate

• Developing and managing detailed project plans, including timelines, budgets, and resource allocation
• Leading cross-functional project teams, coordinating efforts to meet project objectives
• Monitoring project progress, identifying potential risks and issues
• Engaging with stakeholders to manage expectations and provide updates
• Preparing and presenting project reports, status updates, and performance metrics to senior management

Manager

• Take ownership of the end-to-end development and management of Master Informed Consent Forms (ICFs) for clinical trials
• Ensure processes are efficient, high-quality, and fully compliant with global regulatory standards
• Streamline ICF workflows, reducing turnaround times
• Support study teams to deliver impactful clinical research
• Provide subject matter expertise in ICF development, using company templates, processes, and systems
• Prepare study-level Master ICFs from draft to final approval, collaborating with CSM, SSU Manager, CRO, and other stakeholders
• Support country- and site-specific ICF reviews and manage amendments
• Ensure ICF content aligns with study protocols, schedules of events, and regulatory requirements
• Act as SME for ICF processes, systems, and workflows
• Assist with follow-up to audit findings and CAPAs related to ICFs

ICF Manager

• Manage day-to-day site start-up and activation activities, supporting your team to deliver quality outcomes.
• Managing and overseeing the end-to-end study start-up process, including site identification, feasibility, regulatory submissions, and site activation.
• Leading a team of study start-up professionals, providing guidance, mentorship, and support to ensure high performance and successful project delivery.
• Collaborating with sponsors, clinical operations, and regulatory teams to ensure compliance with local and global regulations and timelines for clinical trial initiation.
• Monitoring study start-up metrics, timelines, and budgets to ensure projects are delivered on time and within scope.
• Identifying potential risks and challenges in the start-up process and implementing strategies to mitigate delays or issues.
• Driving continuous improvement initiatives to optimize the study start-up process and enhance overall efficiency.

Manager – Study Start Up

• 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 II

Clinical Research

• Coordinating and conducting clinical trial procedures according to protocol requirements
• Performing technical and clinical requirements of study protocols, i.e., venipuncture, specimen processing, vital signs, electrocardiograms, Holtor monitoring, pulmonary function testing, allergy testing, urine/serum pregnancy testing, strep throat screening, injections (IM or SQ) or any procedure necessary for the protocol as ordered by the investigator
• Collecting and documenting patient data accurately and efficiently
• Assisting in patient recruitment, screening, and enrollment processes
• Providing nursing care and support to trial participants
• Collaborating with interdisciplinary teams to ensure trial compliance and quality data collection

Clinical Research Coordinator, Nurse

Clinical Research Nurse

Clinical Operations

• Accountable for oversight of all assigned studies within the country in accordance with the overall development plan and clinical operations plan and under the direction of the global team (Global Clinical Trial Manager), including adherence to quality, timelines and budget.
• Accountable for planning and executing assigned country study goals and commitments, and as needed, leading, organizing, and participating in regional and/or local meetings and training sessions to implement country-level recruitment plans.
• Develops, builds and maintains optimal relationships with key institutions within the country (i.e. Site Alliance Sites), working closely with the Medical Science Liaisons, Global Site Management and Central Services, and other departments as indicated according to the Site Engagement Strategy.
• Drive the identification and inclusion of sites that have access to and can enroll patients who are from groups that have been historically underrepresented in clinical trials (per FDA Guidance for Industry for Improving Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials).
• Oversees regional study feasibility, site monitoring performance, quality metrics and all relevant activities for assigned studies.
• Drives evidence-based site recommendations and selection.
• Provides support and training for sites to support diverse recruitment and retention, review, assist and optimize site-level diversity plans as needed, check and challenge progress and coordinate and align central efforts across sponsor and CROs.
• Align local and central initiatives and advise and guide on effective community engagement activities.
• Conduct co-monitoring and site identification visits, as needed.
• Collaborates cross-functionally to build and maintain strong relationships and interaction at the country local level (i.e. Medical Science Liaisons, Medical Monitors, Clinical Scientists, etc.) that directly contribute to key study activities and milestones.
• Communicates regularly on country study (ies) status and escalates unresolved issues appropriately to the Regional Clinical Operations Head, North America, Clinical Operations Asset Lead, Clinical Operations Executive Therapeutic Head, and/or Global Study Team.
• Collaborates with the Global Study Team, and when necessary, develops and executes the local implementation of the risk management plans, identifying critical issues for the country and ensuring contingencies are established and captured in the study level risk management plan.
• For in-house studies, works with the Study Start-Up Team to ensure timely submission of all regulatory, IRB and administrative submissions and helps ensure their appropriate approval.
• Collaborates in local quality/compliance reviews, internal audits, and regulatory inspections, ensuring inspection readiness at all times and implementation of Corrective Action Plan for assigned studies.
• Ensures that clinical data from sites are of quality and delivered in accordance with established data entry and cleaning timelines and deliverables.
• Represents country and line reports and provides the Global Study Team with actionable country-specific feedback.
• Works closely with counterparts in the Regional Clinical Operations Organization to discuss and share country best practices, and contribute to process and initiatives that improve quality and effectiveness and that provide visibility to the Regional Clinical Operations organization.
• Ensures that the Incyte Clinical Trial Management and various business intelligence and tracking systems are complete and up to date for assigned studies.
• Proactively incorporate learning and recommendation from study debriefs, best practices and lessons learned.
• Maintains oversight and ensures consistency across studies and alignment across CROs for outsourced studies.
• Makes an active contribution to therapeutic area strategy teams (i.e. Global Study Team, Asset Lead Meetings, etc) ensuring knowledge sharing of regional interest.
• Serves as an active contributor and rotating member on the Protocol Review Committee (PRC).
• Manages issues related to local invoices and provide oversight of any budget reconciliation, in collaboration with Global Clinical Study Manager and relevant departments.

Associate Director – Regional Clinical Operations

• Design and analyse clinical trials, interpreting complex medical data, and contribute to the advancement of innovative treatments and therapies.
• Oversee clinical laboratory operations workstreams, ensuring deliverables meet quality and timeline expectations.
• Ensure client satisfaction by acting as the Client's main contact in all matters regarding ICON Central Laboratories' (ICL) services, including the setup and day-to-day management of studies.
• Attend and represent ICL at Client meetings.
• Manage studies in accordance with Good Clinical Practice.
• Provide Clients with regular study updates and communicate study progress to Clients and PM Leadership in a responsible and professional manner.
• Represent Project Management at internal interdepartmental meetings or interdivisional meetings within ICON.
• Act as the sponsor’s main contact person in all matters regarding our central laboratory services, following up and responding to clinical study specific inquiries from Sponsors, Physicians, CRA and CRO representatives and the ICON Site Services Department.
• Review newly assigned protocols and Amendments.
• Monitor study progress throughout the study, using ICON tools and communicate pertinent information to clients/sponsors.
• Provide client with support on ICO Labs system.

Senior Project Manager, Laboratory

Medical Director

• Provide strategic medical safety leadership and hands-on support for assigned product(s) within a cross-functional environment
• Develop safety strategies and deliver accurate, timely, and high-quality safety input for global regulatory submission documents (e.g. ISS, SCS, narratives) for assigned product(s)
• Conduct safety signal detection and benefit-risk assessment activities, along with routine and ad-hoc aggregate safety data reviews for assigned product(s)
• Lead cross-functional discussions and reviews of existing and emerging aggregate safety data for assigned product(s)
• Contribute to the advancement of the overall safety governance framework and related activities
• Draft and/or review safety sections of clinical and regulatory documents (including study protocols, IBs, Clinical Study Reports, and ICFs)
• Provide medical safety expertise in responses to regulatory authority questions and ensure safety information is complete, accurate, and submitted in a timely manner
• Lead the preparation of periodic safety reports (e.g. PSUR, DSUR), ensuring consistency, quality, and appropriate medical safety content
• Oversee the medical review and assessment of individual case safety reports (ICSRs)
• Confirm reporting criteria and content for expedited reporting and unblinding activities (e.g. SUSARs or urgent safety matters)
• Lead or contribute to the preparation and presentation of safety data for Data Safety Monitoring Board (DSMB) meetings
• Provide medical safety support during internal audits and regulatory inspections
• Assist with the development and maintenance of GPS Standard Operating Procedures (SOPs) and other controlled documents (e.g. work instructions, forms, templates)
• Support adverse event reporting training and cross-functional pharmacovigilance awareness initiatives
• Support the preparation and review of pharmacovigilance agreements with clinical development and commercial partners
• Participate in cross-functional initiatives and project teams
• Perform additional responsibilities as needed to support departmental objectives

• 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

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

Content Writer

• 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

Project Manager

Clinical Research Associate

Project Manager

ICF Manager

Manager – Study Start Up

Clinical Research Associate

Clinical Research Associate II

Clinical Research Coordinator, Nurse

Clinical Research Nurse

Associate Director – Regional Clinical Operations

Senior Project Manager, Laboratory

Medical Director

Study Manager – COPD, OPTAL

Senior Contract Analyst

Informed Consent Writer