Local Study Lead

Mississauga - Ontario - Canada - LifeSciencesAndHealthCare - Pharmaceutical - ProjectManagementAndServices - Academic Bachelor

We’re hiring a Local Study Lead for our client, a global pharmaceutical company, to join their team. This is a 1-year contract position.

Feel free to contact

Diana Grodowski, Account manager

Apply now

About this role

Responsibilities:

  • Accountable for managing and delivering to the medical affairs research budget for their assigned studies (across local and global budgets)
  • Support company auditors and Canadian inspectors related to local research activities
  • Mitigate risk by developing action plans and escalate issues for assigned study projects which are tracking behind agreed upon timelines and collaborate with medical affairs for aligned resolution execution.
  • Proactively contribute to global working groups/projects
  • Participate in team and departmental meetings, process improvement projects, quality audits, generation of performance data, and training activities.

Responsibilities specific to management of IIR Studies:

  • Manage IIR, ISCS studies according to local and global company processes, ICH GCP, and Health Canada regulations.
  • Organize and chair local cross-functional IIR review and approval meetings and facilitate global review process.
  • Liaise with local and global colleagues from Medical, Regulatory, Pharmacovigilance, Legal, and Marketing, where appropriate.
  • Work with Investigators and Study Coordinators throughout study review process, study start-up, recruitment, maintenance, and close-out.
  • Proactively manage study issues and track progress against milestones.
  • Review all study documents - proposals, ICFs, protocols, abstracts, posters and manuscripts; distribute to team and collate comments to communicate to site.
  • Enter and track progress of studies in company systems
  • Create and maintain Trial Master File (TMF); hard copy and electronic study documents.
  • Assess budget for Fair Market Value and negotiate, forecast, and track budget.
  • Work collaboratively with legal to draft and negotiate contracts with investigators and institutions.
  • Work with Local Study Associate to set up studies in financial systems and issue study payments.
  • Proactively update team members on status of studies.
  • Manage investigational product supply to sites.
  • Ensure that site is compliant with serious adverse event (SAE) and other safety information reporting obligations to the company.

Responsibilities specific to management of Observational Studies:

  • Manage all OS study related activities from country confirmation through to study report completion to ensure that study execution is on track and follows company processes and applicable regulatory requirements.
  • Work closely with Study Coordinators and Investigators throughout study.
  • Conduct study feasibility with input from the Therapy Area specialists.
  • Develop country and site specific budgets, provide monthly accruals, initiate and track payments, and provide budget forecast.
  • Adapt global study documents for use in Canada, where necessary.
  • Review, collect, and track completed documents from sites and create and maintain local TMF (hard copy and electronic).
  • Work collaboratively with legal to draft and negotiate contracts with investigators and institutions.
  • Conduct site training and initiation visits and/or webcasts.
  • Track and proactively manage patient recruitment, query resolution, and study close-out activities at the sites.
  • Participate in global study meetings and update global database system (NIS Base)
  • Provide monthly updates to local team on study status
  • For locally initiated OS studies, take on the role of study manager and conduct activities at study level in addition to country and site activities above.

About you

Requirements

  • Bachelors in Science/Life Sciences
  • Previous experience in a similar role
  • Experience within observational studies
  • Experience within investigational studies

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

  • Publication: PUB240867
  • Location: Mississauga
  • Market: LifeSciencesAndHealthCare
  • Hours per week: 40
  • Branche: Pharmaceutical
  • Education level: Academic Bachelor
  • Area of expertise: ProjectManagementAndServices
  • Closing date: January 2, 2020
Apply now

Feel free to contact

DG

Diana Grodowski

Account manager Brunel Canada Toronto

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