Associate Study Manager

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.

• Participate in study planning and set-up activities including vendor management, project management and the coordination of study and implementation plans
• Assist in monitoring the execution of the clinical study deliverables against the specified timelines,  deliverables, and budget as delegated by the GCTM/GECDM
• Contribute to or coordinate preparation and conduct of site initiations, monitors’ workshops (as applicable) and investiagtor meetings (as applicable)
• Coordinate study-level Investigational Product arrangements, accountability and reconciliation
• Manage the process for planning and procuring ancillary clinical supplies, including collaboration with BSM and assay groups to coordinate shipment and analysis of clinical biological samples
• Work with the GCTM/GECDM, LTM and RCTM to develop recruitment strategies
• Monitor the progress of studies, data flow, identifying study related trends/issues and working with the GCTM/GECDM to implement corrective actions when necessary
• Create and manage study specific tools such as recruitment and retention materials and study newsletters
• Process work requests to Study Management Associate (SMA) team
• Contribute to and support with the preparation, writing and review of study related documents including but not limited to: study guides, monitoring plans, e(CRF)s, Investigational Product Information Manual (IPIM), study specific Important Protocol Deviation (IPD) list, subject information sheets, clinical study report, regulatory submissions and publications
• Participate in Line Listing Review

• Support and oversee vendor activities and relationships where assigned
• Compile IRB/EC submission documentation
• Assist with Global Development Operations (GDO) Operational Review preparation
• Participate in and support study team and cross functional meetings including the preparation of meeting agendas and minutes
• Manage global versioning and distribution of informed consent forms (ICFs)
• Prepare and communicate regular updates to the study team
• Support inspection readiness activities (e.g. Study History Document / TMF maintenance and review)
• Work with outsourced vendors to organize and deliver essential documents to the trial master file
• Assist in ensuring that all site and study team members are trained on the conduct of the study and that they understand the study timelines and deliverables; coordinate activities as needed between study team members
• Contribute to ongoing, continuous improvement

What do you need to have?

• Detailed knowledge of International Conference on Harmonization (ICH), Good Clinical Practice (GCP), FDA regulations and guidelines and applicable international regulations and guidelines
• Experience interacting with external vendors (e.g. CROs, Labs etc.)
• Experience with development of prospective site selection criteria
• Understanding of the drug development process and procedures
• Good organization, planning and communication skills
• Advanced computer skills
• Ability to understand technical, scientific and medical information
• Familiar with advanced concepts of clinical research
• BA/BS/BSc in the sciences or RN qualification

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.