For one of our clients located in the Walloon Brabant, we are actively looking for a Senior Clinical Site Manager / Senior CRA.
- Have a Bachelor or a Master (biological science, pharmacy or another health-related discipline)?
- Demonstrate a substantial Site Management experience or equivalent experience in clinical research, with an understanding of clinical trials methodology and terminology?
- Speak English fluently and have a good knowledge of French and/or Dutch?
Then, this is the next step in your career!
As CSM, you are accountable for using your expertise to build and maintain the site relationship and ensure they are set up for success. This includes addressing and resolving site issues and questions.
You will also manage site quality and delivery from site identification through to close-out.
- You act as the company's sole contact with assigned clinical sites
- You use your trial management expertise to oversee the overall integrity of the study and problem-solving skills to promote positive working relationships with the site and staff
- You conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites; you generate visit/contact report
- You review the performance of the trial at designated sites, ensuring the rights and well-being of human subjects are protected and are in accordance with the protocol
- You evaluate the quality and integrity of the reported data, site efficacy, and drug accountability
- You develop patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines Ensure compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s)
- You monitor completeness and quality of Regulatory Documentation and perform site document verification
- You have a Bachelor or a Master (biological science, pharmacy or another health-related discipline)
- You demonstrate substantial Site Management experience or equivalent experience in clinical research, with the understanding of clinical trials methodology and terminology
- You have strong interpersonal, written, and verbal communication skills within a matrixed team
- You have the ability to work in a self-driven capacity, with a sense of urgency and limited need for oversight
- You have a client-focused approach to work; flexible attitude with respect to work assignments and new learning
- You have the ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply the understanding of study protocol(s)
- You work ethically and honestly to promote the development of life-changing treatments for patients
- You have strong computer skills, including but not limited to the knowledge of a Clinical Trial Management System (CTMS), Electronic Document Management System (EDMS), and MS-Office products such as Excel and Word
- You speak English fluently and have a good knowledge of French and/or Dutch