Remote Clinical Trial Manager II​/Gestionnaire dessais cliniques II, Dermatology & Rheumatolog

Position: Remote Clinical Trial Manager II / Gestionnaire dessais cliniques II, Dermatology & Rheumatolog[...]
Location: Victoriaville

Clinical Trial Manager II (CTM II), Dermatology & Rheumatology, Canada
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 CRAs training, identification of quality issues related to site performance and clinical monitoring activities, establishing action plans to address any concerns, and 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 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
RESPONSIBILITIES   Ensures that clinical monitoring activities are performed to the Sponsor’s satisfaction, ensuring timely quality deliverables and in accordance with applicable SOPs, regulations, GCP 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, follow‑up letters, quality control visits and quality assurance audit findings. Summarises 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
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 such as source data verification worksheets
Conducts quality control visits with CRAs
Coordinates and leads CRA meetings
Performs co‑monitoring visits with CRAs
May be involved in business development activities (client meetings, proposal defense meetings, RFPs, RFIs)
IDEAL PROFILE  Education   

B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience
Experience   At least 8 years of clinical research experience including prior monitoring experience and at least 2 years acting as Lead CRA or Clinical Team Leader in the biotechnology, pharmaceutical, and/or CRO industry
Knowledge and skills   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 quick‑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 when possible
Fluent in English (excellent oral and written), French is an asset
Experience in a CRO and in dermatology an asset
Work environment  At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
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  The successful candidate is given the option to work from home anywhere in Canada, or from our headquarters in Montreal in accordance with company policies and public health directives. Occasional visits to our Montreal headquarters may be required or encouraged.
About Indero  Indero is a contract research organization (CRO) specialized in dermatology and rheumatology. Since its beginnings in 2000, our organization has benefited from a solid reputation for the quality of its research and services exceeding the expectations of its clients. Based in Montreal, Indero continues to…