Clinical Trial Associate

This is a fully remote position, open to applicants in France.

📋 Description

• Administer and oversee the Trial Master File (TMF/eTMF) throughout the duration of the study.

• Facilitate the collection, organization, tracking, and reconciliation of study documents from both internal teams and CROs.

• Perform quality reviews and QC checks on the TMF to ensure compliance with ICH-GCP and company procedures.

• Detect and address any missing, outdated, or incomplete study documentation.

• Supervise the archiving of study documents in accordance with regulatory and company standards.

• Assist in the financial management of clinical studies, which includes handling purchase orders, invoices, budget monitoring, commitments, and payment follow-ups.

• Manage transparency reporting and keep documentation for compliance with disclosure regulations.

• Offer operational assistance such as contract management, insurance renewals, clinical supply coordination, and upkeep of legal documents.

• Maintain clinical systems and tracking tools, including CTMS, SAP, SharePoint, and iCap.

• Collaborate with Clinical Research Managers, CROs, vendors, and internal stakeholders to ensure high-quality, timely, and regulatory-compliant delivery of clinical trials.

⛳️ Requirements

• Bachelor's or Master's degree in Life Sciences, Pharmacy, Biology, Health Sciences, or a related discipline.

• Proven experience in Clinical Operations, Clinical Trial Management support, TMF/eTMF management, or Clinical Research Administration within a pharmaceutical, biotechnology, or CRO setting.

• In-depth knowledge of ICH-GCP guidelines, clinical trial processes, and relevant regulatory requirements.

• Demonstrated experience in managing TMF/eTMF systems, ensuring inspection readiness, and maintaining document quality compliance.

• Ability to coordinate efforts among CRMs, CROs, vendors, investigators, and internal departments.

• Experience with clinical study budgets, purchase orders, invoices, and financial management systems.

• Familiarity with CTMS, eTMF platforms, SAP, SharePoint, and document management systems.

• Strong organizational abilities and capability to juggle multiple priorities and deadlines.

• Advanced skills in Microsoft Excel for data analysis and reporting.

• Proficient written and verbal communication skills suitable for international, cross-functional collaboration.

• Fluent in English.

🏝️ Benefits

• An inclusive environment that emphasizes collaboration and individual development.

• A stimulating professional atmosphere that promotes personal and intellectual growth.

• Engaging and diverse projects across full-service, functional service provider, and consulting models.

• Collaboration with industry-leading experts.

• A workplace that values natural talents, encourages boldness, challenges boundaries, and nurtures potential.

• A focus on providing the best employee experience.