Clinical Trial Specialist

Clinical Trial Start-Up Specialist Location: Mississauga, ON – Hybrid (3 days onsite) Contract: 12 months Pay Rate: Up to $51/hr INC | $42/hr T4 Role Overview: We are looking for a Clinical Trial Start-Up Specialist to support the efficient and compliant initiation of Roche-sponsored clinical trials. The role will focus on country and site start-up strategy, regulatory submissions, site activation, process improvements, and collaboration with regional and global teams. Key Responsibilities: Lead country-level study start-up strategy and execution. Oversee site start-up activities, regulatory submissions, and timely site activation. Ensure compliance with ICH-GCP, EU CTR, and local regulations. Manage study amendments throughout the trial lifecycle. Coordinate with CROs, vendors, and external stakeholders. Identify opportunities for process automation, standardization, and efficiency improvements. Collaborate with regional and global teams to align strategies, systems, and timelines. Engage with Ethics Boards, Health Authorities, government, and institutional bodies as required. Support continuous improvement of clinical trial start-up processes. Required Qualifications: Degree in Life Sciences or related field (MD, PhD, MSc/MS, BA/BS or equivalent). Experience in clinical trial start-up and regulatory submissions. Strong understanding of ICH-GCP, EU CTR, and local regulatory requirements. Experience working with CROs/vendors. Experience with clinical trial systems such as Veeva Vault, CTIS, RIM, or similar platforms. Strong communication, organizational, analytical, and problem-solving skills. Ability to work effectively in matrixed, global, and cross-functional environments. Strong attention to detail and ability to manage multiple priorities. Fluent English required; fluency in the host-country language required.

Lead the strategy and execution of country-level clinical trial start-up, focusing on regulatory submissions and site activation. Collaborate with global teams, CROs, and health authorities to ensure compliant and efficient trial initiation.

Requires a degree in Life Sciences and proven experience in clinical trial start-up and regulatory submissions. Proficiency with systems like Veeva Vault and a strong understanding of ICH-GCP and EU CTR are essential.

• Résolution de problèmesSouhaitée
• CommunicationSouhaitée
• Cross-Functional CollaborationSouhaitée

Relevées dans la description du poste. Confirmez les exigences importantes ci-dessus.

• Clinical Trial Start-Up
• Regulatory Submissions
• Site Activation
• ICH-GCP
• EU CTR
• Veeva Vault
• CTIS
• RIM
• CRO Management
• Process Automation
• Stakeholder Coordination
• Analytical Skills
• Problem-Solving
• Organizational Skills
• Cross-functional Collaboration
• Communication

• Healthcare
• Science & Research
• Consulting

Formation minimale

Baccalauréat

Expérience minimale

2+ ans

Postuler avant le

1 oct. 2026

Langue de l’offre

anglais

Heures de travail

40 heures par semaine

Présence au bureau

3 jours par semaine

Niveau d’expérience

Mid-Senior level

Mode de candidature

La candidature directe est offerte