Clinical Site Manager

Proclinical are recruiting for a Clinical Site Manager to work at a leading multinational contract research organisation in Denmark. This is an excellent company to work for, whose clients include many of the world's leading pharmaceutical and medical device companies and they employ over 15,000 personnel in over 50 countries.

This CRO has launched a new clinical operating model to drive effectiveness, reduce hand-offs and increase employee, client and site satisfaction. Within this model, the Clinical Site Manager (CSM), formerly the Clinical Research Associate (CRA), serves as the clinical sites' direct point of contact. The CSM role offers the opportunity to go beyond the role of a typical clinical monitor. CSMs are accountable for using their 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.

Job Responsibilties:

• Act as the company's sole contact with assigned clinical sites
• Use your trial management expertise to oversee overall integrity of the study and problem-solving skills to promote positive working relationships with the site and staff
• Conduct qualification visits (QV), site initiation visits (SIV) and monitoring visits (MV) at assigned clinical sites; generate visit/contact report
• 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 protocol
• Evaluate the quality and integrity of the reported data, site efficacy, and drug accountability
• Develop patient recruitment strategies in conjunction with the clinical site to meet enrolment timelines Ensure compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s)
• Monitor completeness and quality of Regulatory Documentation and perform site document verification

Skills and Requirements:

• Site Management experience or equivalent experience in clinical research, with understanding of clinical trials methodology and terminology
• Educated to degree level (biological science, pharmacy or other health related discipline)
• Demonstrates strong interpersonal, written, and verbal communication skills within a matrixed team
• Ability to work in a self-driven capacity, with a sense of urgency and limited need for oversight
• Client focused approach to work; flexible attitude with respect to work assignments and new learning
• Ability to manage multiple tasks, to evaluate a variety of unpredictable scenarios, and achieve project timelines; apply understanding of study protocol(s)
• Work ethically and honestly to promote the development of life changing treatments for patients
• 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

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Sigrid Jorgensen on +44 203 856 9337 or upload your CV on our website - www.Proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

#LI-SJ1