Clinical Trial Manager

🔥 3 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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Linical

WebsiteLinkedInAll Job Openings

501 - 1000 employees

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Linical is a global Clinical Research Organization (CRO) that partners with biopharmaceutical companies to manage and support clinical trials across various therapeutic areas such as oncology, neurology, psychiatry, immunology, and endocrinology. With extensive expertise in drug development strategy, protocol development, regulatory consulting, and patient recruitment, Linical guides clients through every phase of their clinical development journey. They emphasize quality data capture, personalized service, and overcoming obstacles to ensure successful clinical trials, helping to bring new therapies to patients worldwide. Linical's global reach and award-winning services make them a reliable partner for conducting complex clinical studies.

📋 Description

• Develop the Site Activation Plan and customize study start-up documents • Coordinate site identification, selection and recruitment • Oversee regulatory document collection, review, and ethics submissions • Prepare and review essential study documents • Authorize release of Investigational Product • Coordinate site contracts and budget negotiations • Manage clinical deliverables, project milestones, timelines, and deficiencies • Train, delegate, and oversee CRAs and other study team members • Develop Monitoring Plans, tools, and training materials • Oversee monitoring visit schedules and CRA performance • Review and approve visit reports, follow-up letters, expenses, and timesheets • Perform remote clinical data review in EDC systems and identify enrollment and data-entry trends • Conduct TMF quality-control reviews and ensure regulatory documents are filed appropriately • Manage clinical vendor budgets, contracts, deliverables, and quality • Assist with study budgets, expenses, revenue recognition, scope changes, and invoice review • Perform monitoring of assigned sites and assist with on-site audits • Attend and contribute to investigator, kick-off, client, and project meetings

🎯 Requirements

• Excellent written and verbal communication, presentation skills, conflict management, time management, organizational, interpersonal, and problem-solving skills • Knowledge of project management techniques and tools and proficient in project management software • Strong team-building skills and ability to work successfully in a matrixed team environment • Excellent customer service and relationship-building skills • Excellent working knowledge of ICH, GCP and local guidelines/regulations • Knowledge of all aspects of clinical trial conduct, including systems, study financials and procedures • Ability to prioritize and manage multiple tasks and delegate responsibility as necessary • Dedication to quality in all work tasks and deliverables • Working knowledge of computer systems, applications and operating systems • Life Science degree, nursing background and/or combination of education / experience • Minimum three years of clinical trial management experience • Previous experience in personnel management preferred • Previous experience as a CRA preferred