Clinical Study Manager

🔥 0 minutes ago

🇲🇽 Mexico – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

ICON plc is a global provider of clinical, consulting, and commercial services across various sectors in the healthcare and pharmaceutical industries. They offer a wide range of clinical solutions, including decentralised clinical trials, cardiac safety solutions, early clinical laboratories, and medical imaging. ICON also provides technology solutions that support drug development from early phases to post-marketing. Their therapeutic expertise spans cardiovascular, oncology, internal medicine, and more, with a strong focus on transformative therapies like cell and gene therapies and biosimilars. ICON is recognized as a leading Contract Research Organisation (CRO), regularly providing thought leadership and contributing to industry publications and events. Their services are tailored to optimize clinical trials, offer regulatory intelligence, and deliver real-world evidence through robust data analysis and patient-centric solutions.

📋 Description

• Lead and coordinate project activities for an FSP clinical study management role dedicated to one pharmaceutical company • Support operational delivery in close collaboration with the Global Trial Study Leader • Execute select studies in compliance with ICH GCP, local regulations, SOPs, schedule, budget, and quality standards • Plan and operationally execute specific tasks within assigned clinical trials • Coordinate with functional leads to deliver milestones and meet project objectives • Oversee strategic partners, including CRO/vendor selection, budget and contract negotiation, and performance supervision • Review and approve key monitoring documents and plans, and review monitoring outputs, decisions, and actions • Conduct oversight monitoring visits, as applicable • Review and endorse relevant study plans • Manage and attend study team meetings and review agendas and minutes • Review protocol deviation outcomes and actions to identify trends across sites or studies • Monitor study-level issues, risks, and decisions and implement mitigation strategies • Review and own trial operational data, including CTMS data • Review and provide oversight of internal trial reports • Ensure studies remain inspection ready and support regulatory inspections • Prepare for agency inspections, including document readiness, tracking, storyboard development, and related preparations • Support data review for database lock and CSR writing and review, including appendices • Collect, review, and file study documents for the trial master file and regulatory filing

🎯 Requirements

• 5+ years’ experience in the pharmaceutical industry and/or clinical research organization • 3+ years’ clinical study management oversight • Significant study management support experience, such as clinical trial assistant/associate or lead CRA • Experience in early phase clinical studies or Phase 2 and 3 studies • Experience with global/international studies or programs • Experience in more than one therapeutic area is advantageous • Proven track record of successfully managing projects within scope, time, and budget constraints • Experience in vendor selection and oversight • Strong leadership and organizational skills • Excellent communication and interpersonal skills • Knowledge of global regulatory and compliance requirements for clinical research, including US CFR, EU CTD, and ICH GCP • Awareness of local country requirements may be required • Proficiency in project management tools and methodologies • PMP or PRINCE2 certification is advantageous • Detail-oriented, proactive, and adaptable • Fluent business English, oral and written • Legal right to work in the country where the role is based

🏖️ Benefits

• Competitive base salary and performance related incentives • Health and wellbeing programmes including medical, dental, and vision coverage where applicable • Retirement and pension plans • Life assurance and disability coverage • Employee assistance programmes and wellbeing resources • Learning and development opportunities through structured training and career pathways • Stability, career development and a collaborative environment • Minimal travel; occasional travel opportunity to support a key trial meeting may arise