SMA II - Indore | Zoek India | 0f3b0e
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Indore, Madhya Pradesh
AS PER THE INDUSTRY
Permanent (Full time)
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. Summary The Site Management Associate II (SMA II) is responsible for managing, implementing and monitoring clinical studies, with support, in a team setting according to ICON SOPs, SSPs and all applicable rules and regulations . The responsibilities of this position include, but are not limited to identifying, training/initiating and closing out study sites; conducting remote site monitoring visits and/or targeted on-site visits as needed, conducting remote site management activities, managing study sites and the required protocols, amendments and/or deviations, assuring that data is reported accurately and timelines are maintained. * Recognize, exemplify and adhere to ICON's values, which center on our commitment to People, Clients and Performance * As a member of staff, the employee is expected to embrace and contribute to our culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs. * Positive attitude towards their position and ICON * Ability to work on study teams that are often virtual, multi-cultural, and multi-disciplinary * Serves as the primary contact for sites and investigators participating in studies * Acts as a resource for internal study teams and other ICON departments * Maintains, reviews, and ensures adequacy of information and data contained in site management reports, tracking systems (CTMS or others) and other site management documents * Conducts and completes remote site management activities, with support as needed, according to applicable SOPs and the Site Management Plan * Supports the Research Services Department by applying critical thinking about the business needs of a study and/or Site Management activities * Participates in QA audits as needed * Regularly attends and contributes to project specific and departmental meetings * Assists, as needed, in developing and reviewing study documents * Ability and willingness to travel as needed (drive and fly) - approximately 25 PERCENT of the time * Reviews drug storage and drug accountability procedures (as applicable), in accordance with applicable SOPs * Maintains and archives study documentation and correspondence, as needed * Assists with site contracting process, as needed What you need? * Bachelors degree * Advanced English * 1 years of Clinical research experience