Analyste d’études bilingue – Solutions du monde réel/ Bilingual Study Analyst – Real World Solutions

Analyste d’études bilingue – Solutions du monde réel/ Bilingual Study Analyst – Real World Solutions

Requirements

• Bilingual: You will be required to support, liaise with and/or work with IQVIA customers and/or suppliers across Canada and around the world therefore, a functional knowledge of English and French, both written and spoken, is necessary to perform the duties of this position
• Good understanding of outcomes research theory, and practical knowledge of research project implementation
• Numerate with good quantitative skills
• High competency in using MS Office products including Word, PowerPoint, and Excel
• High level of literacy – able to write reports in clear, accurate, and concise language
• Experience with medical writing
• Understanding of and interest in the Canadian and international health care environment, and evolving industry standards/challenges

Responsibilities

• Support the delivery of projects for our clients; the pharmaceutical industry, governments, and academic centres in Canada, focusing on retrospective and prospective real-world evidence studies
• Contributing to the development of study specific documents (e.g., study protocol, study plans and trackers)
• Supporting site selection by working with the Project Manager and client to assess potential site interest, experience, and ability to participate in the study
• Site contracting by working with the contracts manager, legal department, and sites to ensure the timely execution of contracts
• Preparing IRB/Ethics Review Committee submission and liaison, addressing questions on the study design, and ensuring the timelines for review are kept to a minimum
• Site set-up and training, preparation of study materials, scheduling regular update meetings and ensuring that the sites are keeping up with regular study tasks, such as accessing the electronic data capture (EDC) platform for data entry, and ensuring that sites are fully compliant with the study requirements
• Anticipating and troubleshooting ongoing subject recruitment critical issues such as ensuring sites have adequate recruitment materials on hand and EDC platform access
• Regularly communicating with sites, as per the study requirements, ensuring that data entry is undertaken as per the study protocol, mitigating and tracking protocol deviations
• Working with data managers, medical monitors, etc. to ensure data entry quality and completeness
• Ensuring integrity of the safety reporting process
• Ensuring all site undertakings are compliant with the relevant study operating procedures (SOPs) for that study
• Ensuring site maintenance of the Investigator Site Files (ISF) throughout the study duration
• Supporting the close-out of studies remotely or on-site
• Maintaining the Study Master File (SMF) throughout the study duration
• Attending, supporting, and presenting at client meetings with senior oversight
• Developing presentation material, taking minutes, and tracking of action items
• Supporting dissemination of study findings through the development and submission of high-quality abstracts, posters, and manuscripts according to submission guidelines
• Escalating any issues quickly through the governance process to ensure timely remediation
• Supporting internal and external vendor management (e.g., outreach, quote negotiation, contracting, and set-up)
• Supporting the organization of steering committee meetings and investigator meetings
• Supporting on proposals for business development, as needed

Preferred Qualifications

• Conducting analyses in databases and/or registries
• Longitudinal patient level data analysis