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Clinical Trial Application Specialist
1 month ago
Job Title: Clinical Trial Application Manager
Job Summary:
We are seeking a highly skilled Clinical Trial Application Manager to join our team at EightSix Network. As a key member of our Regulatory Affairs team, you will be responsible for the management and submission of initial Clinical Trial Applications (CTAs), amendments, responses, and updates. This is a renewable contract position.
Key Responsibilities:
- Collaborate with internal cross-functional teams 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.
- 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
About Us:
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