Clinical Trial Manager

🔥 0 minutes ago

🌐 Australia, Singapore, +1 more countries – Remote

🇦🇺 Australia – Remote 🇸🇬 Singapore – Remote 🇰🇷 South Korea – 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 primary clinical point of contact with the client • Develop study clinical documents, plans, forms, manuals, trackers, presentation 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 drive site feasibility processes • 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 timelines and deliverables • Generate and use metric reporting to monitor study performance and communicate issues • Implement and manage the eTMF • Develop and implement CAPA plans with PM, CRAs, and QA • Support GCP audit preparation • Coordinate project-specific resourcing issues with the PM • Escalate CRA performance and site compliance issues • Collaborate with data management and CRAs to ensure data quality and cleaning timelines • Manage investigational product accountability and reconciliation • Assume project management responsibilities when no cross-functional PM is assigned • Support business development and marketing activities • May negotiate site budgets and investigator contracts • May review site visit reports and monitoring execution • May manage clinical vendors and perform clinical data review • May have line-management and supervised-staff workload responsibilities • 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 • Candidates must be legally authorized to work in the country of employment without employer sponsorship