Clinical Trial Manager

🔥 5 hours ago

🇦🇺 Australia – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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 For Medicine

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💼 Consulting

📦 Logistics

💰 $75M Private Equity Round on 2015-12

Healthcare • Consulting • Logistics

Precision For Medicine is a leading organization that specializes in supporting the development and commercialization of innovative therapies, particularly in oncology, rare diseases, and autoimmune conditions. With a comprehensive range of services including clinical trial management, lab services, and biospecimen collection, they integrate advanced biomarker capabilities and manufacturing solutions to streamline the complex clinical development processes. Their mission is to accelerate research and bring life-changing medical solutions to patients by overcoming traditional inefficiencies typically found in the pharmaceutical development landscape.

📋 Description

• Serve as the clinical trial lead responsible for planning, conduct, and operational oversight 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 clinical documents, study plans, informed consent templates, study forms, manuals, CRF completion guidelines, 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 site lists and lead site feasibility processes • Assess enrollment risks and develop country recruitment and retention strategies • Coordinate feasibility, site start-up, enrollment, maintenance, and close-out activities • Lead internal clinical team meetings and set expectations for CRAs and CTAs • Address CRA and site questions and maintain FAQ logs • Support investigator meetings • Review or approve investigational product release packages • Oversee submissions and approvals to Competent Authorities and IRB/Ethics Committees • Develop clinical monitoring strategies and ensure timelines and quality deliverables • Generate and use metrics from CTMS, data-management query trends, and outstanding monitoring reports • Implement and manage the eTMF • Collaborate with PM, CRAs, and QA on CAPA development, implementation, and closure • Assist sites, internal staff, and CRAs with GCP audit preparation • Address project resourcing issues and escalate CRA performance or site compliance issues • Collaborate with data management and CRAs to ensure data quality and timely data cleaning • Manage investigational product accountability and reconciliation • Assume project management responsibilities when a cross-functional PM is not assigned • Support business development and marketing activities • May negotiate site budgets and investigator contracts • May review site visit reports and monitoring-plan execution • May manage clinical vendors • May perform clinical data review and query generation • May have line-management responsibilities and manage supervised staff workload • Perform other duties assigned by management

🎯 Requirements

• Bachelor’s degree or equivalent combination of education/experience in science or health-related field • 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 health-volunteer clinical trials • Mandarin language proficiency required to support Mandarin-speaking clients • Experience with Microsoft Office products: Outlook, Word, Excel, and PowerPoint • Excellent communication and interpersonal skills to effectively interface with others in a team setting • Excellent organizational skills, attention to detail, and customer service demeanor • Ability to travel domestically and internationally, including overnight stays

🏖️ Benefits

• Ability to work remotely in Australia • Regular full-time employment • Opportunity to work with new technologies, scientific expertise, laboratory expertise, and advanced data sciences • Focus on oncology and rare disease • Equal Opportunity Employer • Reasonable accommodation available for applicants with disabilities