Analyste d’études / Study Analyst, Real World Solutions

at  IQVIA

De la recherche au monde réel, IQVIA réunit les technologies, les ressources et l’expertise dont nos clients ont besoin pour saisir la prochaine occasion. IQVIA utilise la science des données humaines – l’intégration de la science des données, de la technologie et de la science humaine – pour aider les clients à répondre aux besoins actuels et aux occasions futures. Pour assurer le fonctionnement de la science des données humaines, il faut une intégration transparente de données inégalées, d’analyses avancées, de technologies transformatrices et d’une expertise approfondie du domaine.
IQVIA est un chef de file mondial dans l’utilisation des données, de la technologie, de l’analyse avancée et de l’expertise humaine pour aider les clients à faire progresser les soins de santé et la santé humaine. En collaboration avec les entreprises que nous servons, nous contribuons à mettre en place un système de santé plus moderne, plus efficace et plus efficient. Ensemble, nous créons des solutions innovantes qui transforment les activités et les résultats pour les patients.
L’équipe Real World Solutions au Canada répond aux besoins des clients en matière de stratégie d’accès au marché, d’économie de la santé et de recherche sur les résultats, de collecte d’informations à partir de multiples bases de données sur les soins de santé au Canada et de production de données probantes du monde réel par le biais d’études locales de phase IV de conception innovante.
Nous offrons un service canadien aux clients grâce à une équipe agile locale hautement qualifiée. Nous disposons de solutions technologiques solides pour travailler avec les médecins et les patients, tout en conservant une infrastructure simple, agile et flexible afin de garantir la proximité avec les clients.

EXPERIENCE:

You will have been working in one of the following environments for one to two years:

• A study or clinical trial support role in an academic or hospital setting
• A study or clinical trial support role in a clinical research organization (CRO)
• A study or clinical trial support role in a pharmaceutical company
• You may be a clinical research assistant (CRA) who wishes to undertake career advancement but is no longer wishing to travel as much

TECHNICAL SKILLS AND KNOWLEDGE (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/Vous devrez soutenir, assurer la liaison avec et/ou travailler avec des [clients et/ou fournisseurs] d’IQVIA partout au Canada et à travers le monde, par conséquent, une connaissance fonctionnelle de l’anglais et du français, tant à l’écrit qu’à l’oral, est nécessaire à l’exercice des fonctions de ce poste.
• 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

TECHNICAL SKILLS AND KNOWLEDGE (ASSETS):

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

PERSONAL SKILLS AND BEHAVIORS:

• A friendly attitude
• A desire to do high quality work
• Ability to adapt quickly to situations and various social styles
• Strong communication skills (written and verbal)
• A team player with a desire to take a lead and make things happen
• A desire to manage several stakeholders with competing priorities
• Demonstrable analytical, interpretative, and problem-solving skills
• Exceptional detail-orientation
• A good sense of urgency with the ability to prioritize tasks and manage time
• Ability to organize a list of tasks into logical steps and maintain progress
• Future leadership potential and desire to build a career with a top global corporation
• Desire to constantly learn and take on new challenges
  Education: graduation with a Bachelor/Master of Science degree with a specialization in life sciences, health sciences, physician, nursing, pharmacy, or similar.

Support the delivery of projects for our clients; the pharmaceutical industry, governments, and academic centres. Canada, focusing on retrospective and prospective real-world evidence studies.
Unlike the role of a traditional Clinical Research Associate, the Study Analyst works the full continuum of the study, from start up, investigator meetings, client calls, data collection, right through to closeout.
Working with other team members you will support the study Project Manager with services to support research sites and investigators in Canada, focusing on retrospective and prospective real-world evidence studies.

As a Study Analyst, you will be responsible for such tasks including, but not limited to:

• 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 asses 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
• Ensuring all site undertakings are compliant with the relevant study operating procedures (SOPs) for that study
• 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 support
• Escalating any issues quickly through the governance process to ensure timely remediation
• Supporting on proposals for business development, as needed

You are expected to work with supervision, as part of a project team, and to take responsibility for timely and high quality delivery of defined tasks.