The Clinical Trial Manager (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 position is a hybrid role with a strategic component (leading EU CTM efforts) and a hands-on component (performing some in person and telephone monitoring visits).

This role will be perfect for you if:

• You enjoy working with a growing, mid-sized CRO where you can build professional relationships with professionals at all levels and be involved in strategic projects
• You bring previous experience in monitoring sites and in managing the clinical monitoring portion of clinical projects
• Dermatology is a therapeutic area you enjoy or want to learn more about

RESPONSIBILITIES

• Leads specific CTM efforts in Poland and other EU countries with the guidance of the Clinical Monitoring team's leadership (based in Canada);
• 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;
• Performs site visits in Poland (site qualification, site initiation, site monitoring and close-out) and limited telephone visits in other European countries (site qualification and site initiation);
• 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 8 years of overall clinical research experience in the biotechnology, pharmaceutical, and/or contract research organization (CRO) industry.
• At least 2 years of experience as a lead CRA, Clinical Trial Leader, or Clinical Trial Manager.
• Previous experience performing all types of monitoring visits as a CRA;
• Experience with registry studies is an asset;
• Experience in a CRO and in dermatology is an asset.

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;
• Regular travel (up to 60% of the time once regular travel can resume);
• Fluent in English and Polish (excellent oral and written).

The work environment

At Innovaderm, you will work with brilliant and driven professionals. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities. 

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

• Work from home
• Renewable contract opportunity with a growing company

About Innovaderm

Innovaderm 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, Innovaderm continues to grow and expand in North America and Europe.