Clinical Development Project Manager
An innovative and leading biopharmaceutical company is currently recruiting for a Clinical Development Project Manager. The company is focussed on the discovery and development of innovative therapeutic and diagnostic solutions in chronic diseases where there are considerable unmet medical needs. Based in France, this is an exciting opportunity to bring expertise and skills to an established and in-demand company.
- Coordinating national or international clinical trials in relation with the internal teams and providers involved.
- Ensuring the implementation and monitoring of clinical trials: documentation, management of providers, monitoring of investigator sites, regulatory and budgetary aspects, etc.
- Contributing to the creation, review or validation of clinical documents such as plans, protocols and amendments, informed consent forms, plans, etc.
- Attending and contributing, if necessary, to expert scientific committees, investigative meetings, conferences.
- Ensuring that projects are carried out in accordance with the protocol, Standard Operating Procedures (SOP), ICH / Good Clinical Practice regulations, as well as the manuals and procedures specific to the study.
- Participating in the review of the clinical study report.
- Participating in monitoring the study quality indicators and contribute to the definition of appropriate measures in collaboration with the study team (the level of autonomy for this activity may vary depending on the level of experience of the candidate).
- Monitoring discrepancies, identify their cause and follow up on the problem until it is resolved.
- Working with the quality department to help identify potential quality issues.
- Coordinating the quality audits organised by the sponsor and ensure the implementation of Corrective Action Preventive Action (CAPA) by the CROs.
- Participating in inspection preparation activities for assigned clinical trials.
- Participating in the development of processes and SOPs.
Skills and Requirements:
- A minimum bachelor's degree and 5 diplomas.
- At least 2 years of experience in the management of clinical trials.
- Experience in our therapeutic areas is a plus.
- Past experiences have allowed you to develop your skills in project or team management in the context of clinical studies.
- Coordinate a project in close collaboration with various internal and external stakeholders.
- Experience in outsourcing management (CROs) would be a plus.
- Master good clinical practices and adhere to the principles of Quality Assurance;
- Recognised for your autonomy, thoroughness, method and organisation.
- Your sense of service and communication is appreciated.
- Demonstrate strong analytical skills, a spirit of synthesis and an open mind.
- Fluent in English, both written and spoken. Your vocabulary is contemporary and adapted to an international working environment. A similar level in French is a plus.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Patrick Aguie at 0203 854 1077 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.