ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.
the Clinical Trial Manager / Clinical Study Manager is accountable for the day to day planning, executing and reporting, (from site feasibility up to and including study site close-out), of assigned Innovative Medicines Phase I-IV Global Drug Development (GDD) studies in compliance with company’s processes and regulatory requirements.
The CSM is the single point of contact and regional study team lead, within the Cluster, for the assigned studies. The CSM is responsible for assuring aligned communication with Country/Cluster Clinical Research Associates (CRAs), CRA Managers and other key Country associates on the execution and progress of their studies. The CSM is accountable to communicate with and support relationships with clinical investigators. The CSM collaborates with Country medical/clinical trial colleagues on the execution and delivery of their assigned studies.
Trial Monitoring strategy
- In collaboration with the Trial Monitoring key stakeholders (CSM Group Head, Regional Operations Manager (ROM), local/global medical, Trial Operations Manager (TOM), and global clinical assists in the development of local study execution plans and timeline commitments for a Country/Cluster
- Participates in the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
Allocation, initiation and conduct of trials
- Supports study feasibility and country patient commitments in collaboration with Country/Cluster Trial Monitoring and Medical. Collects and manages input to the study protocol, and operational aspects of the study
- Leads site selection in collaboration with Country/Cluster Trial Monitoring and Medical
- Ensures that study start-up activities are conducted and completed on time, including preparation of IRB/EC submission packages, review of Informed Consent Forms, engaging Regulatory Affairs/CTA Hub for Health Authorities submissions, as required, in collaboration with Country/Cluster Trial Monitoring stakeholders
- Works with local Drug Supply Management, to forecast local IMP and comparator needs as appropriate. Ensures IMP is available to commence and complete assigned trial/assigned trial sites
- Oversees local vendor selection and performance as needed. Serves as main contact for quality/compliance issues, escalating as necessary
- Ensures sites are prepared for “Ready to Initiate Site” (checkpoint), inclusive of written confirmation, and ensures all documentation is in place for initial and subsequent drug release in collaboration with the local Qualified Person(s)
- Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites, and internal Country/Cluster personnel
- Drives the conduct of the study, (tracks status, maintains study level reporting systems, oversees forecasts, progress, and mitigation plans), to ensure all study operational aspects are on track
- Ensures recruitment targets are met and reviews enrolment at the site level including responsibility for approval of enrolling above site targets. Is responsible to set up contingency plan to ensure recruitment targets are achieved in accordance with trial execution plan
- Oversees local clinical team activities to achieve study timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to company standards and local and international regulations
- Leads/chairs local study team meetings or supports Sr. CSM in the conduct of local study team meetings, participates in global clinical trial team meetings, as required and is the single point of contact for the conduct of assigned studies or study sites
- Maintains oversight of country level or assigned site level data management activities, including timely understanding of screen failure reasons and discontinuation rates, review of patient profiles, and proactively identifies data entry issues (on quality and timing) to mitigate queries, proactively identifies query resolution issues
- Coordinates the study handover process with the CRAs and their managers to ensure proper documentation and communication, when necessary
- Tracks that all study close–out activities are performed in a timely manner, in collaboration with CRAs and key study stakeholders
Delivery of quality data and compliance to quality standards
- Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
- Conducts or coordinates local investigator meetings as needed
- Ensures documentation of training (global/regional/local investigator meeting minutes, participants’ lists, certificates, etc.) is archived in the Trial Master File
- Evaluates potential challenges/risks within the protocol and operational aspects of the study; assessing impacts, developing risk management plans and communicating/ escalating to regions and/or global teams, as appropriate
- Is the escalation point for issues in monitoring visit reports (MVRs) for the assigned studies, post CRA Manager review (may act as primary reviewer in countries where CRA Managers do not exist). Is responsible for evaluating trends identified in MVRs and communicating/escalating to regions and/or global teams, as appropriate. Communicates with CRAs and their managers to ensure issue resolution in a timely manner
- Provides feedback about the quality of monitoring activities to CRA Managers and local QA as appropriate
- Supports inspection readiness and submission preparation for monitoring related activities and assists with internal audits and HA inspections, as required, and ensures implementation of corrective actions within specified timelines
- Participates in multidisciplinary taskforces to support continuous improvement initiatives
Budget and productivity
- Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study start up under the direction of their manager
- Tracks study budget with appropriate study budget responsible in Country/Cluster. Ensures timely TCF preparation and submission in collaboration with the TCF specialist in the Country/Cluster
- Processes invoiceable items for site level clinical study activities to allow timely payments
- Minimum 5 years’ experience in clinical research in a role that oversees (project management) and/or is leading clinical trials & study teams
- Capable of leading in a matrix environment, without direct reports
- Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution.
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA) and local/National Health Authorities regulations.
- Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)
- Fluency in English
- Communicates effectively in a local/global matrixed environment
Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.
