Clinical Trial Manager II, Dermatology – Rheumatology

Job not on LinkedIn

🔥 16 hours ago

🇦🇺 Australia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Operationally manage and oversee clinical investigative sites and clinical monitoring deliverables for clinical trials • Train clinical research associates (CRAs) • Identify quality issues related to site performance and clinical monitoring activities • Establish action plans to address concerns and ensure timelines are met • Lead specific CTM efforts in Australia, APAC, and other EU countries under Clinical Monitoring leadership based in Canada • Ensure monitoring activities meet Sponsor expectations and comply with SOPs, regulations, good clinical practices, and study-specific requirements • Identify quality issues and trends through project meetings, site communications, site visit reports, follow-up letters, quality control visits, and quality assurance audit findings • Summarize findings and establish corrective action plans • Perform site visits in Poland, including site qualification, site initiation, site monitoring, and close-out • Conduct limited telephone visits in other European countries • Serve as point of contact for CRAs and Lead CRAs on assigned projects • Mentor and oversee CRAs and Lead CRAs • Review site visit reports and track metrics for compliance • Contribute to Clinical Monitoring Plan development • Prepare and conduct project-specific CRA training • Develop annotated site visit reports and monitoring tools, including source data verification worksheets • Conduct quality control visits with CRAs • Coordinate and lead CRA meetings • Perform co-monitoring visits with CRAs • Participate in business development activities such as client meetings, proposal defense meetings, RFPs, and RFIs

🎯 Requirements

• Previous experience in monitoring sites and managing the clinical monitoring portion of clinical projects • Expertise in Dermatology and Rheumatology therapeutic areas • Ability to lead specific CTM efforts in Australia, APAC, and other EU countries • Knowledge of applicable standard operating procedures (SOPs), regulations, good clinical practices, and study-specific requirements • Experience identifying quality issues and trends related to site performance and clinical monitoring activities • Experience establishing action plans and corrective actions • Experience performing site qualification, site initiation, site monitoring, and close-out visits • Experience with limited telephone visits in European countries • Ability to serve as a point of contact for CRAs and Lead CRAs • Ability to provide mentoring and oversight of CRAs and Lead CRAs • Experience reviewing site visit reports and tracking site visit report metrics • Ability to contribute to Clinical Monitoring Plan development • Experience preparing and conducting project-specific CRA training • Ability to develop annotated site visit reports and monitoring tools, including source data verification worksheets • Experience 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 • Complete benefits • Ongoing learning and development • Attractive advancement opportunities • Accommodations throughout the recruitment and selection process for applicants with disabilities, upon request