Clinical Trial Manager II, Dermatology & Rheumatology CRO, Australia

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 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)).