Local Study Associate

Mississauga - Ontario - Canada - Life Sciences & Health Care - Pharmaceutical - Project Management & Services - Academic Bachelor

The Local Study Associate (LSA), Medical Affairs is responsible for study specific logistical and operational aspects of local Medical Affairs studies, including Investigator Initiated Research Studies (IIRs) and Observational Studies (OS). These activities must be performed to a compliance standard expected of high quality and reputable medical research activities. The LSA is part of the Medical Research Team and will work collaboratively with the Local Study Manager and the Local Study Leads as well as the Medical Affairs therapy area teams to deliver study related tasks.

Feel free to contact

Sinead McLaughlin, Account manager

Apply now

About this role

Responsibilities

  • Partner with the Medical Research Team in the preparation, collection, and tracking of study documentation
  • Perform quality check of study files within the Trial Master File (TMF)
  • Calculate and track study budget and process payments based on activity completed by study sites
  • Work with Medical Research Team as well as Investigators and their Study Coordinators throughout study review process, study start-up, recruitment, maintenance, and close-out
  • Assist in updating databases and global systems related to study management
  • Participate in the generation of performance data and metrics including identification of studies lagging behind expected milestone deliverables
  • Participate in and contribute to team meetings, best practice sharing, process improvement initiatives, and audit readiness activities
  • May manage maintenance and close-out phase IIRs and OSs

About you

Requirements

  • Bachelor of Science (or equivalent) or higher science/healthcare degree
  • 2+ years of clinical research experience (ICH/GCP) preferred; knowledge of drug development process
  • Experience with managing Trial Master Files, archiving and readying documents for audit
  • Exceptional organizational and project management skills
  • Effective written and verbal English communication skills.
  • Ability to organize information and analyze trends for the Medical Research Team.
  • Compliance mindset, with attention to detail and excellent follow through
  • Ability to take on leadership, decision-making, and issue resolution and work collaboratively within a team
  • Ability to effectively work with all Microsoft suite programs, with expert knowledge of Excel and Power Point.
  • Strong self-motivation skills and ability to effectively manage a high workload with minimal supervision while working in a collaborative environment

What we offer

Why work with Brunel? We are proud to offer exciting career opportunities from over 100 offices globally in 42 countries. Advancing your career takes time and effort – let us match you to your ideal position.

About us

Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 40 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.

Summary

  • Vacancy number: PUB251181
  • Location: Mississauga
  • Market: Life Sciences & Health Care
  • hours per week: 40
  • Branch: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of Expertise: Project Management & Services
  • Closing date: Saturday, March 14, 2020
Apply now

Feel free to contact

SM

Sinead McLaughlin

Account manager Brunel Energy Canada Calgary

+1 403 539 5009

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