Clinical Trial Manager II (CTM II)

Clinical Trial Manager II (CTM II), Canada - North America

The Clinical Trial Manager II (CTM) 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, as well as 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 and rheumatology are therapeutic areas 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 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)).

IDEAL PROFILE

Education 

• B.Sc. in a field relevant to clinical research, nursing degree and/or equivalent experience.

Experience 

• At least 5 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.

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 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.

OUR COMPANY

The work environment

At Innovaderm, 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.

As a Clinical Trial Manager, you will be eligible for the following perks:

• Permanent full-time position.
• Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities).
• Ongoing learning and development.

About Innovaderm

Innovaderm is a contract research organization (CRO) specialized in dermatology with a team of over 175 employees. 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, Innovaderm continues to grow and expand in North America.

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

We thank you for your application and please note that only those selected for an interview will be contacted.