Clinical Trial Manager

🔥 5 hours ago

🇦🇺 Australia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 19%

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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Precision Medicine Group

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2012

💼 Consulting

🏥 Healthcare

📦 Logistics

💰 $35.2M Venture Round on 2021-03

Consulting • Healthcare • Logistics

Precision Medicine Group is a global team of experts that specializes in precision medicine, which combines advanced lab sciences, translational informatics, regulatory affairs, payer insights, and marketing communications. The company focuses on overcoming product development and commercialization challenges for pharmaceutical and life sciences clients. Their services include biomarker-driven research and development, as well as commercialization support for life science organizations from launch to product maturity. Precision Medicine Group operates through two main arms: Precision for Medicine and Precision AQ, specializing in clinical and commercial solutions respectively.

📋 Description

• Serve as the clinical trial lead responsible for planning, conduct, and oversight of the operational portion of clinical studies • Ensure studies comply with protocols, SOPs, ICH-GCP, and applicable regulatory requirements • Act as the primary clinical point of contact with the client • Collaborate with the Project Manager on monthly invoicing and clinical budget variance management • Develop study-related clinical documents, plans, forms, manuals, trackers, slides, and training materials • Identify training needs for CRAs and third-party vendors and present training at Investigator and Study Kick-off meetings • Generate potential site lists and drive site feasibility • Develop country recruitment and retention strategies • Coordinate feasibility, site start-up, enrollment, maintenance, and close-out procedures • Lead internal clinical team meetings and set expectations for CRAs and CTAs • Address CRA and site questions and maintain FAQ logs • Support investigator meetings and review or approve investigational product release packages • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies and track study metrics to meet timelines and quality requirements • Implement and manage the eTMF • Develop and implement CAPA plans with the Project Manager, CRAs, and QA • Assist sites, internal staff, and CRAs with GCP audit preparation • Manage resourcing issues, escalate CRA performance and site compliance issues, and ensure data quality • Manage investigational product processes, including drug accountability and reconciliation • Assume project management responsibilities when a cross-functional Project Manager is not assigned • Support business development and marketing activities • Potentially negotiate site budgets and investigator contracts, manage clinical vendors, review site visit reports, perform clinical data review, and manage supervised staff workloads • Perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field; advanced degree preferred • Minimum of 5–8 years of clinical research experience or proven competencies for the position, with significant clinical monitoring experience • Experience in Phase 1 FIH and healthy volunteer clinical trials • Mandarin language proficiency required to support Mandarin-speaking clients • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) • Excellent communication and interpersonal skills to effectively interface with others in a team setting • Excellent organizational skills, attention to detail, and a customer service demeanor • Ability to travel domestically and internationally, including overnight stays

🏖️ Benefits

• Regular full-time employment • Ability to travel domestically and internationally, including overnight stays