As a Study Delivery Specialist, you will be joining the world's largest and most comprehensive clinical research organization, powered by healthcare intelligence. You will provide support to the clinical trial team at the global level impacting directly the project's success.What you will be doing:Keeping up to date with all the changes/required knowledge on ICH GCP, sponsor's written standards, and attending appropriate training sessions.May be responsible for supporting multiple studies simultaneously and must prioritize appropriately to meet business needs to ensure delivery of results.Management of Access and Study Trackers: Maintain all the study trackers and access.Analysis of various reports.Timely distribution of dashboards and reports to the study team.System Related Support: Managing study systems.TMF Management and Maintenance: Managing TMF activities both for Inhouse and FSO trials.Provide timely follow-up with the stakeholders to improve TMF compliance.General Areas: Common email group to support the issues related to CSAP, CTMS.Clinical admin support. Support to studies where there is no requirement of SDS.Work closely with SDS/SM to manage the activities post SAC and until final archival.You are:Excellent technical/IT skills. Able to understand the impact of technology on studies and to use and develop computer skills while making appropriate use of sponsor's systems/software.Knowledge of ICH GCP relevant operational procedures, systems, and quality guidelines regarding clinical studies.Able to work independently as well as in a team.Professional attitude with good customer focus (internal and external).Time Management as system updates, eTMF, etc. need to be done in a timely manner.Very good communication skills - high English level.1-2 years of prior experience in clinical operations as CTA, CPA, or similar.Knowledgeable of main systems (vTMF, mCTMS) and the willingness and ability to continuously learn and become highly competent in using sponsor's evolving systems and tech.What ICON can offer you:Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family.Various annual leave entitlements.A range of health insurance offerings to suit you and your family's needs.Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family's well-being.Life assurance.#J-18808-Ljbffr
