RTSM/eCOA Manager

Emploi pas sur LinkedIn

🕒 il y a 3 jours

🔔 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

• Manage day-to-day scientific operations activities, supporting your team to deliver quality outcomes • Support design, development, configuration, and lifecycle management of RTSM/IRT/eCOA systems to meet protocol and study requirements • Partner with Clinical Operations and study teams to understand RTSM/IRT/eCOA requirements and ensure alignment on scope, timelines, and deliverables • Develop and manage User Requirement Specifications (URS) and system design documentation • Ensure completion, review, and filing of validation and testing documentation in accordance with quality standards • Provide ongoing RTSM/IRT subject matter expertise to cross‑functional study teams throughout the study lifecycle • Identify, investigate, and resolve system defects and issues in collaboration with Quality, Clinical Operations, and vendors on deviations • Manage change control and emergency system changes • Serve as the primary operational interface between study teams, RTSM vendors, and internal functional teams • Ensure RTSM systems and documentation comply with SOPs and applicable regulations • Oversee quality reviews, validation documentation approval • Managing RTSM user access requests, modifications, and removals, including oversight of periodic access reviews and audit readiness • Alignment with SOPs, regulatory expectations, and system security controls • Support the development and implement standardized RTSM processes • Document end‑to‑end RTSM workflows and associated guidance • Identify process gaps and drive continuous improvement aligned with SOPs and regulations • Ensure RTSM processes support inspection readiness and consistent execution • Develop role‑based RTSM training curricula and materials • Ensure training aligns with processes, system functionality, and regulatory expectations

🎯 Exigences

• Bachelor’s degree required (BA/BS) • Minimum 5 years of operational experience in clinical trials within a pharmaceutical company and/or CRO • Strong knowledge of the clinical trial process, with deep expertise in RTSM/IRT (IVRS/IWRS) eCOA systems • End‑to‑end experience managing RTSM system builds and updates • Proven experience leading User Acceptance Testing (UAT) and validation activities • Hands‑on experience working with RTSM/IRT/eCOA vendors; vendor management experience required • Project management experience managing complex, matrixed studies or programs • Familiarity with testing and issue‑tracking tools • Ability to independently identify issues, analyze root causes, and implement solutions in a complex environment • Strong communication, negotiation, and stakeholder‑management skills • Demonstrated leadership, organization, and prioritization capabilities

🏖️ 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