Clinical Trial Manager II, Dermatology – Rheumatology

This is a fully remote position, open to applicants in Australia.

📋 Description

• Manage and supervise clinical investigative sites as well as oversee clinical monitoring deliverables for clinical trials.

• Provide training for clinical research associates (CRAs).

• Detect quality issues related to site performance and clinical monitoring activities.

• Develop action plans to resolve concerns and ensure deadlines are adhered to.

• Lead specific Clinical Trial Management (CTM) initiatives in Australia, APAC, and various EU countries under the Clinical Monitoring leadership located in Canada.

• Ensure that monitoring activities align with Sponsor expectations and comply with standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements.

• Identify quality issues and trends through project meetings, communications with sites, site visit reports, follow-up letters, quality control visits, and findings from quality assurance audits.

• Summarize findings and implement corrective action plans.

• Conduct site visits in Poland, which include site qualification, initiation, monitoring, and close-out.

• Execute limited telephone visits in other European countries.

• Act as the main point of contact for CRAs and Lead CRAs on assigned projects.

• Mentor and supervise CRAs and Lead CRAs.

• Review site visit reports and monitor metrics for compliance.

• Contribute to the development of the Clinical Monitoring Plan.

• Prepare and deliver project-specific training for CRAs.

• Create annotated site visit reports and monitoring tools, including source data verification worksheets.

• Conduct quality control visits alongside CRAs.

• Organize and lead CRA meetings.

• Perform co-monitoring visits with CRAs.

• Engage in business development activities, including client meetings, proposal defense meetings, RFPs, and RFIs.

⛳️ Requirements

• Prior experience in monitoring sites and managing the clinical monitoring aspects of clinical projects.

• In-depth knowledge in the therapeutic areas of Dermatology and Rheumatology.

• Capability to lead specific CTM efforts in Australia, APAC, and other EU countries.

• Familiarity with relevant standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements.

• Experience in identifying quality issues and trends concerning site performance and clinical monitoring activities.

• Proven track record in establishing action plans and corrective measures.

• Experience conducting site qualification, initiation, monitoring, and close-out visits.

• Experience with limited telephone visits in European countries.

• Ability to act as a point of contact for CRAs and Lead CRAs.

• Capability to provide mentorship and oversight for CRAs and Lead CRAs.

• Experience in reviewing site visit reports and tracking related metrics.

• Ability to contribute to the development of the Clinical Monitoring Plan.

• Experience in preparing and conducting project-specific CRA training.

• Ability to create annotated site visit reports and monitoring tools, including source data verification worksheets.

• Experience in conducting quality control and co-monitoring visits.

• Ability to coordinate and lead CRA meetings.

• Willingness to participate in business development activities, including client meetings, proposal defense meetings, RFPs, and RFIs.

🏝️ Benefits

• Flexible work schedule.

• Permanent full-time position.

• Comprehensive benefits package.

• Opportunities for ongoing learning and development.

• Attractive advancement opportunities.

• Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request.