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Senior Clinical Trial Manager
Innovaderm Research Inc.Senior Clinical Trial Manager overseeing clinical trial operations and monitoring deliverables. Collaborating with CRAs in a remote environment at a mid-sized CRO specializing in dermatology.
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Responsible for the operational management and oversight of clinical investigative sites and clinical monitoring deliverables of clinical trials
- Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables
- Identifies quality issues and trends related to site performance and clinical monitoring activities
- Summarizes findings and establishes action plans for corrective actions
- Serves as a point of contact for CRAs and Lead CRAs for assigned projects
- Provides mentoring and oversight of CRAs and Lead CRAs
- Performs site visit report review for assigned projects
- Contributes to the development of the Clinical Monitoring Plan
- Prepares and conducts project-specific training for CRAs
- Develops annotated site visit reports and monitoring tools
- Conducts quality control visits with CRAs
- Coordinates and leads CRA meetings
- May be involved in business development activities
Requirements
What you’ll need- B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
- At least 8 years of clinical research experience including prior monitoring experience
- At least 2 years of experience acting in a Lead CRA or Clinical Team Leader role in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry
- Strong knowledge of ICH/GCP standards and applicable regulatory requirements
- Excellent mastery of Microsoft Office suite (Word, Excel, Power Point)
- Ability to work in a fast-paced evolving environment and establish good relationships with colleagues, sites and sponsors
- Excellent leadership, organizational, time management and multi-tasking skills
- Excellent judgement and problem-solving skills
- Occasional travel (up to 10% of the time), including some travel outside of the country once possible
- Fluent in English (excellent oral and written)
- Experience in a CRO and in dermatology an asset.
Benefits
Comp & perks- Flexible work schedule / work schedule : Home-based position
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
clinical researchclinical monitoringsite performance analysisquality controlClinical Monitoring Plan developmentproject-specific trainingannotated site visit reportsmonitoring tools developmentLead CRA experiencebiotechnology experience
Soft Skills
leadershiporganizational skillstime managementmulti-taskingjudgementproblem-solvingrelationship buildingmentoringcommunicationadaptability
Certifications
B.Sc. in clinical research or nursingICH/GCP knowledge