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Study Start Up Associate Ii - French Speaking/Office Based
Company | ICON plc |
Address | Montreal, Quebec, Canada |
Employment type | FULL_TIME |
Salary | |
Category | Pharmaceutical Manufacturing |
Expires | 2023-08-03 |
Posted at | 10 months ago |
ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organizations.
- Ensure that the overall process is focused on quality, efficiency and cost containment for a particular region / sub division within the CDP group, under the general mentorship of Mgr/Sr. Manager – Central Services or Designee.
- Coordinate, balance and facilitate activities related to the completion of Critical Document Package (CDP) and the IP release checklist (SST004-SOP-F01) in accordance with ICH GCP guidelines and all applicable regulations, laws, ethical standards, other guidelines, sponsor requirements
- Proficient project management skills.
- A high school diploma or local equivalent
- Bachelor’s Degree preferably in Life Sciences
- Minimum of 1 years’ experience or understanding of clinical study start up requirements and activities.
- Experience of Clinical Trial operations and meeting regulatory guidelines
- S’assurer que l’ensemble du processus met l’accent sur la qualité, l’efficacité et la limitation des coûts pour une région/sous-division en particulier dans le groupe CDP, sous la conduite générale du gestionnaire principal – Services centraux ou de la personne désignée.
- Coordonner, concilier et faciliter les activités liées à la finalisation des trousses des documents essentiels (CDP) et de la liste de vérification de publication du produit expérimental (SST004-SOP-F01) conformément aux directives ICH GCP et à toutes les réglementations, lois, normes éthiques, autres directives et exigences du promoteur applicables
- De l’expérience quant aux activités liées aux essais cliniques et de l’expérience quant à la conformité aux directives réglementaires
- Un diplôme d’étude secondaire ou un équivalent local
- Un baccalauréat de préférence en sciences biologiques
- D’excellentes compétences en gestion de projet
- Un minimum d’un an d’expérience ou de compréhension des exigences et des activités relatives au démarrage des études cliniques
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