Clinical Trial Associate

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Excelya

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2014

💼 Consulting

🏥 Healthcare

📦 Logistics

Consulting • Healthcare • Logistics

Excelya is a leading global Contract Research Organization (CRO) focused on advancing healthcare through innovative solutions and expert guidance. With a presence in 28 countries, Excelya supports biotech, pharmaceutical, and medical device companies by offering full-service, functional service provider (FSP), and resourcing solutions across a broad spectrum of therapeutic areas. The company's unique business model emphasizes collaboration and flexible services, enabling clients to deliver life-changing therapies effectively.

📋 Description

• Manage and maintain the Trial Master File (TMF/eTMF) throughout the study lifecycle • Coordinate collection, filing, tracking, and reconciliation of study documents from internal teams and CROs • Conduct TMF quality reviews and QC checks for ICH-GCP and company-procedure compliance • Identify and resolve missing, outdated, or incomplete study documentation • Oversee study document archiving according to regulatory and company requirements • Support clinical-study financial management, including purchase orders, invoices, budget tracking, commitments, and payment follow-up • Coordinate transparency reporting and maintain documentation for disclosure-regulation compliance • Provide operational support including contract management, insurance renewals, clinical supply coordination, and legal-document maintenance • Maintain clinical systems and tracking tools including CTMS, SAP, SharePoint, and iCap • Liaise with Clinical Research Managers, CROs, vendors, and internal stakeholders to support quality, timeline, and regulatory delivery of clinical trials

🎯 Requirements

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biology, Health Sciences, or a related field • Experience in Clinical Operations, Clinical Trial Management support, TMF/eTMF management, or Clinical Research Administration in a pharmaceutical, biotechnology, or CRO environment • Strong knowledge of ICH-GCP guidelines, clinical trial processes, and applicable regulatory requirements • Experience managing TMF/eTMF systems, inspection readiness, and document quality compliance • Ability to coordinate CRMs, CROs, vendors, investigators, and internal departments • Experience with clinical-study budgets, purchase orders, invoices, and financial systems • Familiarity with CTMS, eTMF platforms, SAP, SharePoint, and document management systems • Strong organizational skills and ability to manage multiple priorities and deadlines • Advanced Microsoft Excel data analysis and reporting skills • Effective written and verbal communication skills for international, cross-functional collaboration • Fluent in English

🏖️ Benefits

• Inclusive environment emphasizing collaboration and individual growth • Stimulating professional environment encouraging personal and intellectual growth • Diverse and stimulating projects through full-service, functional service provider, and consulting models • Collaboration with leading experts • Environment valuing natural talents, encouraging boldness, pushing boundaries, and cultivating potential • Best employee experience focus