- Remote, Canada
- Remote
- Full-time · Senior
- 8+ years
The Senior Clinical Trial Manager (Sr CTM), Dermatology & Rheumatology, is responsible for the operational management and oversight of the clinical investigative sites as well as the clinical monitoring deliverables of clinical trials.
Responsibilities
- Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with applicable standard operating procedures (SOPs), regulations, good clinical practices and study-specific requirements
- Identifies quality issues and trends related to site performance and clinical monitoring activities through project meetings, site communications, site visit reports and follow-up letters, quality control visits, and quality assurance audit findings. Summarizes findings and establishes action plans to bring corrective actions
- Serves as a point of contact for CRAs and Lead CRAs for assigned projects
- Provides mentoring/oversight of CRAs and Lead CRAs
- Performs site visit report review for assigned projects and tracks site visit report metrics to ensure compliance
Requirements
- B.Sc. in a field relevant to clinical research
- nursing degree
- Nice to have: Dermatology experience
- Nice to have: CRO experience