[Hiring] Senior Clinical Trial Manager @Indero

Role Description

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. 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 in a collaborative, mid-sized CRO where you can build strong relationships and have a visible impact on your projects.
• You bring solid experience leading the clinical monitoring activities of complex clinical trials, supporting CRAs, and ensuring quality and timely study delivery.
• You enjoy taking ownership, solving operational challenges, and partnering closely with cross-functional teams, sites, and sponsors.

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.
• 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, requests for proposals (RFPs), requests for information (RFIs)).

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 and 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

• Flexible work schedule
• Home-based position
• RRSP
• Ongoing learning and development

Company Description

Indero is a contract research organization (CRO) specialized in dermatology. 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 grow and expand in North America and Europe.

Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.

Indero only accepts applicants who can legally work in Canada.