Global Study Manager

🕒 Yesterday

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟡 Mid-level

🟠 Senior

👔 Manager

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ICON plc

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1990

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• Leads/contributes to the preparation of delegated study documents (e.g. Informed Consent Form, master Clinical Study Agreement etc) • Maintains and facilitates interactions with internal functions including but not limited to Enablement, Data Management, Procurement, Regulatory, Patient Safety and Quality Assurance, and external functions including the CROs and other external service providers to ensure an efficient study delivery to time, costs and quality objectives • Contributes to the planning and conduct of internal and external meetings (e.g. Investigators’/Monitors’ meeting) • Ensures the supply of Investigational product and study materials by liaising with Clinical Supply Chain or external service providers as appropriate • Proactively contributes to risk and issue identification, development of mitigation and/or action plans for identified risks and issues • Ensures that all study documents in scope of GSM’s responsibilities are complete and verified for quality in Trial Master File • Supports GSD/GSAD with budget management, such as external service provider invoice reconciliation • Adheres to global clinical processes, procedural documents, applicable Quality & Compliance manual documents and international guidelines such as ICH/GCP to ensure study is inspection ready at all times • Supports GSADs in project management as per agreed delegation • For outsourced studies, supports GSD/GSAD in management of the CRO Project Manager to ensure study delivery according to agreed timelines, budget and quality standards, while ensuring that the appropriate level of oversight of the CRO is maintained and documented throughout the lifecycle of the study, in accordance with relevant SOPs and guidelines (e.g. description of services and transfer of obligations)

🎯 Requirements

• University degree (or equivalent), preferably in medical or biological sciences or discipline associated with clinical research • Relevant experience from within the pharmaceutical industry or similar organization or academic experience, preferably of at least 3 years • Experience in global study management focused heavily on the management of vendors and external partners • Knowledge of clinical development / drug development process in various phases of development and therapy areas • Excellent knowledge of international guidelines ICH/GCP • Excellent communication and relationship building skills, including external service provider management skills • Good project management skills • Demonstrated ability to collaborate as well as work independently • Demonstrated leadership skills • Computer proficiency, advanced computer skills in day-to-day tasks • Excellent verbal and written communication in English • Early phase oncology experience required.

🏖️ 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