Clinical Project Manager
Clinical Project Manager
Our client is a medical device company dedicated to improving health outcomes for cancer patients. The company's products address the pressing medical need for better tools to detect cancer during surgery in order to improve clinical outcomes and reduce healthcare costs.
Purpose of the role:
The Clinical Project Manager is responsible for site selection, set up and management of designated clinical studies to ensure they are delivered in accordance with the business requirements.
- The Clinical Project Manager will establish good working relationships with international investigators and clinical site staff with the ability to motivate and support.
- Manage a CRO bought in to run overseas studies
- Responsible for all day-to-day decisions and issues relating to the site management of the clinical studies - medical device experience is preferred in this regard.
- The Clinical Project Manager will perform site assessment visits, initiation visits, monitoring visits and close-down visits in accordance with all the applicable regulations.
- Perform submissions to Competent Authorities, Research Ethics Committees and hospital departments to expedite the approval process.
- Manage external resources allocated to a clinical study to ensure quality and deliverables are maintained on target.
- The Clinical Project Manager will maintain compliance with the department procedures and participate in the development and improvement of internal processes.
- Maintain a high standard of filing accuracy to ensure the study master files are well organised and all essential documentation available.
- Ensure any safety issues arising during the conduct of clinical studies are reported immediately to the regulatory department.
- The Clinical Project Manager will maintain the highest ethical, clinical and scientific standards ensuring both the safety and wellbeing of study participants and good/rigorous scientific practice.
- Be flexible in providing assistance to the clinical team with any designated tasks to support the clinical research programme to ensure project timelines are met.
- The Clinical Project Manager will have practical experience of managing clinical studies including site management and monitoring
- Experience of working with CRO
- Plan and prioritise own workload to ensure timelines are met, and often work with competing deadlines
- Independent judgement employed in problem solving site management issues with limited supervision
- Communication, presentation and facilitation skills including effective negotiation and persuasion skills
- Highly responsible and efficient in dealing with issues in a timely and professional manner
- Operate in a confidential and professional manner at all times
- Ideally degree educated in a scientific field or practical work experience
- Clinical Project Management track record in life sciences
- Working in house and managing a CRO
- The Clinical Project Manager will have knowledge and experience of clinical study design of European clinical studies ideally in the medical device arena.
- Monitoring of clinical studies and resolution of issues at study sites in accordance with all applicable regulations.
- Overseeing data management function and approving plans for database lock/CSR
- UK and European travel
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales