[Hiring] Clinical Trial Manager II @Indero

Role Description

The Clinical Trial Manager II (CTM II), 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. This includes but is not limited to:

• Clinical research associate (CRA) training
• Identification of quality issues related to site performance and clinical monitoring activities
• Establishing action plans to address any concerns
• Ensuring timelines are met

This role will be perfect for you if:

• You enjoy working with a Canadian-owned mid-sized CRO where you can build professional relationships with your colleagues at all levels
• You bring previous experience in managing the clinical monitoring portion of clinical projects
• Dermatology is a therapeutic area you enjoy or want to learn more about

Qualifications

• 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), French is an asset
• Experience in a CRO and in dermatology an asset

Requirements

• Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction
• Identifies quality issues and trends related to site performance and clinical monitoring activities
• 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
• Contributes to the development of the Clinical Monitoring Plan
• Prepares and conducts project-specific training for the CRAs
• Develops the annotated site visit reports and monitoring tools
• Conducts quality control visits with CRAs
• Coordinates and leads CRA meetings
• Performs co-monitoring visits with CRAs
• May be involved in business development activities

Benefits

• Flexible work schedule
• Full-time contract position
• Complete benefits (medical, dental, vision, vacation, personal days, virtual medical clinic, social activities)
• Ongoing learning and development
• Work location options (work from home anywhere in Canada, or from headquarters in Montreal)
• Occasional visits to our Montreal headquarters may be required or encouraged