Clinical Trial Manager

🔥 12 minutes ago

🌐 Australia, Singapore, +1 more countries – Remote

🇦🇺 Australia – Remote 🇸🇬 Singapore – Remote 🇰🇷 South Korea – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 20%

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 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 • Collaborate with the Project Manager on monthly invoicing and clinical budget variance management • Develop clinical study documents, plans, forms, manuals, 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 potential site lists and drive site feasibility • Identify enrollment risks and develop country recruitment and retention strategies • Manage communication and relationships with investigators and study teams throughout feasibility, start-up, enrollment, maintenance, and closeout • 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 track study timelines and deliverables • Generate and use metrics reporting, including CTMS, DM query trends, and outstanding monitoring reports • Implement and manage the eTMF • Collaborate with PM, CRAs, and QA on CAPA development, implementation, and closure • Support GCP audit preparation • Address 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 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 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; 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 proficient required to support Mandarin-speaking clients • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint) • Excellent communication and interpersonal skills • Excellent organizational skills and attention to detail • 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

🏖️ Benefits

• Regular full-time employment • Remote work arrangement in Australia, Singapore, or South Korea • Equal opportunity employment • Reasonable accommodation for applicants with disabilities