Assistant, Clinical Trials

2 weeks ago

Laval, Canada Servier Full time

**Date posted**:Feb 9, 2023**City**:Laval**Country/Region**:CA**Type of Contract**:Unlimited contract**Job Requisition ID**:2275Assistant, Clinical Trials / Assistant(e), Études cliniques
- Servier Canada is a wholly owned subsidiary of the Servier Research Group, a private French pharmaceutical firm active in over 140 countries around the world. Entirely independent, the Group reinvests 25% of its turnover in Research and Development and applies all profits towards development. The Group’s growth is driven by a constant search for innovation in 4 areas of excellence - oncology, cardiovascular, immuno-inflammatory and neuropsychiatric diseases.- Servier Canada's goal is to create a climate of mutual support and encouragement throughout our organization. We make every effort to achieve this through our work-life balance initiatives, our competitive benefits programs, employee development and our reward and recognition programs. At Servier, we believe that the key to success lies in our most asset: our employees.- Servier Canada est une filiale du groupe de Recherche Servier, une compagnie pharmaceutique internationale gouvernée par une Fondation, ayant son siège en France. S’appuyant sur une solide implantation internationale dans 149 pays, Servier emploie 22 000 personnes dans le monde. Totalement indépendant, le Groupe réinvestit 25% de son chiffre d’affaires en Recherche et Développement et utilise tous les bénéfices au profit de son développement. La croissance du Groupe repose sur la recherche constante d’innovation dans cinq domaines d’excellence - les maladies cardiovasculaires, immuno-inflammatoires et neuropsychiatriques, les cancers et le diabète, ainsi que sur une activité dans les médicaments génériques de qualité.- L'objectif de Servier Canada est de créer un climat de soutien et d'encouragement mutuels dans toute l'entreprise. Nous déployons tous les efforts nécessaires pour y parvenir grâce à nos initiatives de conciliation de la vie professionnelle avec la vie personnelle, nos programmes d'avantages sociaux concurrentiels, le perfectionnement de nos employés et nos programmes de récompense et de reconnaissance. Chez Servier, nous estimons que la clé du succès réside dans notre atout le plus important : nos employés.- We are currently recruiting for an
- **Assistant, Clinical Trials**. Based in Montreal, and working side-by-side with the responsible Clinical Operations Project Manager and Clinical Trial Manager, the Assistant, Clinical Trials coordinates the logístical aspects of clinical trials and participates in a variety of clinical activities to ensure the efficient conduct of Servier’s clinical research studies.- Status of position: Permanent, full-time- Start date: March 2023- Location of position: Laval**RESPONSIBILITIES**
- Works in close collaboration with the Project Manager and Clinical Research Associates
- Closely assists in the management of study progress (from planning to study close-out) to ensure adherence to intended timelines and achievement of study goals while ensuring quality in accordance with Health Canada, FDA, GCP and ICH guidelines
- Assists in the development of critical study documents, including ICFs, operational documents, study reference documents, study newsletters, site materials, and other study-related documents
- Updates in real-time IT systems used in the management of clinical studies (e.g. CTMS, IMP management tool, eTMF, Sharepoint, etc.)
- Assists in the preparation of investigator meetings and other meetings
- Reviews and maintains study-level training documentation
- Reviews study-specific essential regulatory document packets prior to site activation
- Prepares the investigator's binders (when necessary) for clinical sites prior to study initiation
- Ensures the submission of documents to, and the maintenance of, the Trial Master File (TMF), and coordinates the review of the electronic TMF to ensure inspection-readiness at all times
- Manages the dispatch of IMP equipment and documents to sites
- Assists CRAs in the preparation of monitoring visits/activities (initiation, follow-up, termination) when necessary
- Liaises with investigators and clinical site staff as appropriate to ensure optimal sponsor-site relationships
- Liaises with contract research organizations (CROs) and other clinical vendors as directed to ensure deliverables are met and methods of communication are developed to facilitate efficient workflow
- Supports preparation activities for Health Canada or FDA inspections as well as internal audits
- Participates in SOP/OPM template development and review
- Provides guidance and shares learning and expertise within and across teams

**SKILLS and EDUCATION**
- Bachelor degree or DEC in science with relevant experience
- Ability to learn on the job and work independently
- Strong organizational skills
- Strong teaming abilities
- Well familiar with Outlook, Word, Excel, PowerPoint and additional

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