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.
Requirements
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 and Rheumatology are therapeutic areas you have expertise in
RESPONSIBILITIES
- Leads specific CTM efforts in Australia APAC 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)).
Our company
The work environment At Indero, you will work with brilliant and driven colleagues. Our values are integrity, commitment and teamwork. We offer a stimulating work environment and attractive advancement opportunities.
As a Clinical Operations Manager, you will be eligible for the following perks:
- Flexible work schedule
- Permanent full-time position
- Complete advantages
- Ongoing learning and development
About Indero
Indero is a contract research organization (CRO) specialized in dermatology with a team of over 350 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, Indero continues to grow and expand in North America and in Europe.
Indero is committed to providing equitable treatment and equal chance to all individuals. As such, Indero 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.
Description de poste
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Profil recherché
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Notre entreprise
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📌 Clinical Trial Manager II, Dermatology & Rheumatology CRO, Australia (Sydney)
🏢 Indero
📍 Sydney