Do you recognize yourself in below skills & competences:
- Organizational and Multitasking Abilities: manage multiple tasks and prioritize effectively in a fast-paced environment, ensuring all aspects of a clinical study are on track and deadlines are met.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook): skilled in using Office tools to create and manage documents, spreadsheets, presentations, and email communications, which are crucial for document management, reporting, and correspondence.
- Familiarity with Clinical Trial Management Systems (CTMS): knowledge of CTMS software to track and manage clinical trial activities, including site management, patient recruitment, data entry, and compliance.
- Knowledge of Clinical Trial Documentation (e.g., content of Investigator Site File): proficient in preparing and reviewing trial documentation, ensuring accuracy and completeness, which is critical for regulatory compliance and audit-readiness.
- Attention to Detail: ensure accuracy, compliance, and consistency throughout the clinical trial documentation.
- Effective Communication Skills: strong ability to communicate both in writing and verbally with cross-functional teams, clinical sites, and stakeholders to ensure smooth trial operations and resolve issues quickly.
- Problem-Solving & Initiative: identify challenges and take proactive steps to address these ensuring compliance with regulations.
- Self-Motivated & Independent Worker: effective in independently managing trial related documentation.
In this role, you will have the opportunity to:
- Assist with the coordination and management of clinical trial activities, including trial preparation, start-up, monitoring, and close-out.
- Support the preparation of clinical trial documentation.
- Maintain trial-related documents and ensure compliance with applicable regulations, standards, and guidelines (ICH-GCP, ISO14155, …).
- Manage and track trial specific processes, documentation and deliverables to ensure projects stay on track.
- Collaborate with the sites to obtain and update essential documentation in compliance with ISO/GCP, procedural documents and local regulations throughout the trial.
- Ensure proper collection and distribution of clinical study materials, including investigational products and supplies where applicable.
- Maintain Trial Master Files (TMF) and ensure audit-readiness.
- Provide support to the Project Manager and CRAs as needed.
- Facilitate communication and collaboration between study sites and other stakeholders, such as sponsor team, CROs, vendors and Ethics Committees.
- Actively participate in study team meetings.
The essential requirements for the job include:
- A Bachelor or Master degree in a scientific, biological, or medical science field.
- Minimum of 1 year experience in clinical research or equivalent by education or relevant experience.
- Good understanding of clinical trial processes and regulations.
- Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook).
- Multilingual proficiency can be advantageous for international trials.
