About the Job
Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.
This role is an exciting opportunity to contribute to a dynamic, ambitious team in Clinical Operations. You will play a critical part in driving innovation and making an impact in the clinical research space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.
Key responsibilities :
- Manage and maintain the Trial Master File (TMF/eTMF), ensuring completeness, accuracy, compliance, and inspection readiness throughout the study lifecycle.
- Coordinate TMF documentation activities, including collection, filing, tracking, and reconciliation of study documents from internal teams and CROs.
- Conduct TMF quality reviews and QC checks to ensure compliance with ICH-GCP requirements and company procedures.
- Ensure timely identification and resolution of missing, outdated, or incomplete study documentation.
- Oversee study document archiving activities in accordance with regulatory and company requirements.
- Support financial management of clinical studies, including purchase orders, invoices, budget tracking, commitments, and payment follow-up.
- Coordinate transparency reporting activities and maintain documentation required for compliance with local and international disclosure regulations.
- Provide operational support for clinical studies, including contract management, insurance renewals, clinical supply coordination, and maintenance of essential legal documents.
- Maintain and update clinical systems and tracking tools (CTMS, SAP, SharePoint, iCap, and related platforms) to ensure accurate study status reporting.
- Act as a key operational liaison between Clinical Research Managers, CROs, vendors, and internal stakeholders, supporting the successful delivery of clinical trials within quality, timeline, and regulatory requirements.
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, Trial Master File (TMF/eTMF) management, or Clinical Research Administration within the pharmaceutical, biotechnology, or CRO environment. Strong knowledge of ICH-GCP guidelines, clinical trial processes, and applicable regulatory requirements. Managing and maintaining TMF/eTMF systems, ensuring inspection readiness and document quality compliance.
- Proven ability to coordinate multiple stakeholders, including CRMs, CROs, vendors, investigators, and internal departments.
- Experience with financial and administrative aspects of clinical studies, including budget tracking, purchase orders, invoices, and financial systems.
- Familiarity with clinical systems and tools such as CTMS, eTMF platforms, SAP, SharePoint, and document management systems.
- Strong organizational skills with the ability to manage multiple priorities and meet deadlines in a fast-paced environment.
- Excellent command of Microsoft Excel with advanced data analysis and reporting skills.
- Effective written and verbal communication skills, with the ability to work collaboratively in an international and cross-functional environment.
- Fluent in English
Benefits
Why join us?
At Excelya, we combine a passion for science with the enthusiasm of teamwork to redefine excellence in healthcare.
Here's what makes us unique:
We are a young and ambitious healthcare company, bringing together 900 Excelyates, driven by the goal of becoming the leading mid-sized CRO in Europe, while offering the best employee experience.
Our "one-stop provider" service model—combining full-service, functional service provider, and consulting—allows you to grow through diverse and stimulating projects. By collaborating with leading experts, you will contribute to the development of scientific, operational, and human knowledge, all in service of improving the patient journey.
Excelling with kindness means evolving in an environment that values your natural talents, encourages boldness, pushes boundaries, and cultivates your potential, so that you can fully contribute to our shared mission.
