Clinical Research Manager

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🌐 Italy, Poland, +1 more countries – Remote

🇮🇹 Italy – Remote 🇵🇱 Poland – Remote 🇪🇸 Spain – Remote

💵 €63k - €65k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• Manage day-to-day clinical operations activities for assigned projects in accordance with study protocols, contracts, SOPs, ICH-GCP guidelines, and applicable regulations. • Serve as the primary sponsor contact for operational project-specific issues and study deliverables. • Lead, coach, and support CRAs, ensuring project-specific training requirements are completed and documented. • Oversee site quality and monitoring deliverables through direct supervision and guidance of study teams. • Develop and implement study monitoring plans, site training plans, and verification initiatives. • Coordinate investigator meetings and support site and country-level study reporting activities. • Ensure study processes and operational strategies remain practical and effective from feasibility through study closeout. • Act as the primary point of contact for CRAs and monitoring teams, providing guidance on site-related challenges and escalations. • Support recruitment and monitoring strategies to optimize study performance. • Conduct co-monitoring visits to ensure quality oversight and consistency across monitoring activities. • Review and approve monitoring visit reports, ensuring timely resolution and escalation of identified issues. • Review monitoring schedules and site visit calendars to ensure compliance with monitoring plans. • Monitor protocol deviations, data listings, and quality metrics to proactively identify risks and implement mitigation strategies. • Lead study team meetings and provide regular updates to Project Managers regarding site and country performance. • Ensure accurate maintenance of study documentation and Trial Master File (TMF) quality, when delegated. • Review CTMS data to ensure timely and accurate recording of country, site, and subject information. • Support investigator payment tracking and approval processes when delegated. • Collaborate with Project Managers on CRA onboarding, training, and handover activities. • Contribute to study communications, newsletters, and operational updates. • Provide project insights related to resource utilization, revenue recognition, and forecasting activities. • Participate in Investigator Meetings and present monitoring requirements and expectations when required. • Promote proactive issue resolution and a solution-oriented approach across study teams. • Partner with CRA Line Managers regarding study assignments, workload planning, and performance discussions. • Support business development initiatives, proposals, budget development, and bid defense activities as required.

🎯 Requirements

• Bachelor's degree in Life Sciences, Clinical Research, Nursing, Pharmacy, or another health-related field. • Minimum of 5 years of clinical research experience. • Significant experience as a Clinical Research Associate (CRA) with independent on-site monitoring responsibilities. • Minimum 1 year experience as an Unmasked CRA / CRM in an Ophthalmology study. • Experience coordinating or overseeing clinical trial operations at a study, country, or regional level. • Strong understanding of clinical trial processes from start-up through closeout. • In-depth knowledge of Good Clinical Practice (ICH-GCP), regulatory requirements, and clinical research standards. • Candidates must be located in Poland, Spain, or Italy. • For Italy-based candidates, applications are welcomed from candidates belonging to protected categories under art. 1 L. 68/99.

🏖️ Benefits

• Competitive compensation package • Lunch vouchers • Health insurance • Pension • Car allowance where applicable • Opportunity for personal and professional growth • Opportunity to work on diverse and impactful clinical development programs • Collaboration with talented colleagues across the globe