Clinical Trial Application Manager (renewable contract)
Remote - Quebec or Ontario
Introduction
We are hiring a Clinical Trial Application Manager for our client to work remotely in either Quebec or Ontario. This position is primarily responsible for the Regulatory Affairs project management and submission of initial Clinical Trial Applications (CTAs), amendments, responses, and updates.
This is a renewable contract position.
Responsibilities
- Collaborate with internal cross-functional teams (eg. Regulatory, Regulatory CMC, Clinical, etc.) to ensure high-quality regulatory submission of initial CTAs, amendments, responses, and updates.
- Ensure pre-CTA meeting requests, initial CTA applications, and maintenance of CTAs through the duration of clinical studies are in alignment with internal defined strategies to meet agreed upon timelines and in compliance with Health Canada (HC) Regulations and issued due dates.
Ensure clinical supply labels adhere to local regulations.
- Maintenance of internal databases updates in timely manner as required.
- Provide Regulatory CTA expertise in support of clinical study feasibility and start up activities as needed.
- Oversight and accountability for study-related submission activities for electronic Trial Master File (eTMF).
- Support corporate audits and HC inspections of study sites as necessary.
- Maintain awareness and knowledge of new and changing CTA requirements.
Requirements
- University degree in Health Sciences
- Minimum 2 years of experience in Regulatory Affairs.
- Self-motivated, action and result oriented
- Excellent negotiation, communication, and strong interpersonal skills
- Good organization and planning skills.
- Ability to multitask and manage ambiguity / versatility
- Critical decision-making
- Strong knowledge of drug development, clinical study management, Health Canada requirements, ICH, GCP, site management and monitoring
- Experience in the pharmaceutical industry in drug development including clinical research and Regulatory Affairs
- English (written and spoken)
- French is an asset
- MS Outlook, Word, Excel, PowerPoint, Adobe Acrobat
- Veeva Vault database familiarity is an asset
What We Offer
Why apply through Brunel? Finding the next step in your career can be a fulltime job in itself. We manage the process for you : from submitting your resume to coordinating interviews to extending offers and assisting with on-boarding.
We’ll get you going while you get on with the job.
About Us
Brunel has a reputation for working with some of the best in the business. That’s what we continually strive for. Over 45 years, we’ve created a global network of interesting clients and talented individuals working together through a vast array of services.
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