Clinical Trial Manager II
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Job Description
Clinical Trial Manager II overseeing clinical trials in dermatology and rheumatology at Indero. Managing clinical monitoring deliverables and ensuring quality in clinical research operations.
Responsibilities:
- Responsible for the operational management and oversight of clinical investigative sites
- Ensures that clinical monitoring activities are performed correctly and timely
- Identifies quality issues and trends related to site performance
- Serves as a point of contact for CRAs and Lead CRAs for assigned projects
- Provides mentoring and oversight of CRAs and Lead CRAs
- Prepares and conducts project-specific training for the CRAs
- Develops annotated site visit reports and monitoring tools
- Coordinates and leads CRA meetings
Requirements:
- 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)
- Fluent in English (excellent oral and written), French is an asset
- Experience in a CRO and in dermatology an asset.
Benefits:
- Flexible work schedule
- Complete benefits (medical, dental, vision, vacation, personal days, virtual medical clinic, social activities)
- Ongoing learning and development
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