ST-Coordinator, Clinical R&D (8 months, Summer 2023, co-op)

Date: Jan 25, 2023

Location: North York, ON, CA, M9L 1T9

Company: Apotex

 

About Apotex Inc.

Apotex Inc. is a proudly Canadian, global pharmaceutical company that produces high-quality, affordable medicines for patients around the world. Apotex employs almost 8,000 people worldwide in manufacturing, R&D, and commercial operations.  Apotex Inc. exports to more than 100 countries and territories and operates in more than 45 countries, with a significant presence in Canada, the US, Mexico, and India. Through vertical integration, Apotex is comprised of multiple divisions and affiliates including Apotex Inc., focused on generics; Apobiologix, a division of Apotex Inc. focused on biosimilar development; Aveva, an affiliate of Apotex Inc. fully integrated global developer and manufacturer of complete transdermal solutions; Apotex Consumer Products, a division of Apotex Inc. focused on brand name products; and Global Active Pharmaceutical Ingredients (GAPI), a division of Apotex Inc. focused on the manufacturing of active pharmaceutical ingredients (API) for Apotex and third parties. For more information visit: www.apotex.com.

Job Summary

If you are looking to gain experience and knowledge about generic bioequivalence clinical trials and manage a time-driven project, then this job is for you.  This position requires a detail-oriented individual to perform data review for a database migration, assist with Clinical Trial Management File (TMF) archival (both paper and electronic) and maintenance of project management trackers and tools.

This role involves the review of a large volume of generic bioequivalence clinical trial project management data through manual (visual) and electronic data comparison to support a database migration.   Additionally, the incumbent has the opportunity to work with our highly experienced team to support TMF archival for various generic bioequivalence clinical trials that are conducted around the world.  This role requires the incumbent to demonstrate high attention to detail while working towards aggressive timelines.

Job Responsibilities

  • Data review and quality control checks of project management data for a clinical database migration project via manual and electronic comparison methods
  • Aid in Trial Management File archival (both paper and electronic) for Apotex-sponsored generic bioequivalence studies conducted globally
  • Data entry for various project management trackers and scientific tools (MS Access-, MS Project- and Excel-based)
  • Data mining of database information
  • Works in a safe manner collaborating as a team member to achieve all outcomes
  • Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion
  • Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies
  • All other relevant duties as assigned

Job Requirements

  • Education: Must be enrolled in a recognized post-secondary Co-op education program, with a focus in a scientific area – applicants with an added computer science background are an asset
  • Knowledge, Skills and Abilities: Must have excellent verbal and written communication skills, be detail-oriented, timeline driven and work well under pressure
  • Experience: Must have solid Microsoft Office skills (such as Word and Excel, experience with MS Access and MS Project is a benefit) and the ability to work independently and in a team setting

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process.  If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.