Global Study Manager

🕒 il y a 1 jour

🔔 Pennsylvania – Distant

🔔 Pennsylvania – Remote

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

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ICON plc

Site WebLinkedInTous les Emplois

10 000+ employés

Fondée en 1990

💊 Pharmaceutique

🧬 Biotechnologie

⚕️ Assurance santé

Pharmaceuticals • Biotechnology • Healthcare Insurance

ICON plc est un fournisseur mondial de services cliniques, de conseil et commerciaux à travers divers secteurs des industries de la santé et pharmaceutique. Ils offrent une vaste gamme de solutions cliniques, incluant des essais cliniques décentralisés, des solutions de sécurité cardiaque, des laboratoires cliniques précoces et de l'imagerie médicale. ICON fournit également des solutions technologiques qui soutiennent le développement de médicaments depuis les premières phases jusqu'à la post-commercialisation. Leur expertise thérapeutique couvre les domaines cardiovasculaire, oncologie, médecine interne et plus encore, avec un fort accent sur les thérapies transformatrices telles que les thérapies cellulaires et géniques ainsi que les biosimilaires. ICON est reconnu comme un leader dans le domaine de l'Organisation de Recherche Clinique (CRO), apportant régulièrement un leadership éclairé et contribuant à des publications et événements de l'industrie. Leurs services sont conçus pour optimiser les essais cliniques, offrir de l'intelligence réglementaire et fournir des preuves du monde réel à travers une analyse de données robuste et des solutions centrées sur le patient.

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)

🎯 Exigences

• 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.

🏖️ Avantages

• 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