Clinical Trials Manager

An exciting opportunity has arisen for a Clinical Trials Manager to join a global biopharmaceutical company based in West London. A very patient-focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.

In partnership with Clinical Research, Medical Affairs and other Development Operations functions, Clinical Operations ensures that all clinical trial activities are performed in accordance with applicable SOPs, company policies and regulatory guidelines to provide timely delivery of high quality clinical data to support global registration and commercialization of the company's products.

Job Responsibilities:

• Works with Clinical Program Managers to manage the European component of global clinical trials and/or the entire process of a local clinical trial, with the ability to identify issues and adapt to changes
• Interacts with cross-functional teams internally and externally to ensure trial progress.
• Will incorporate study logistics and planning to accomplish study objectives.
• Will serve as the primary point of contact for CROs, addressing questions and applying knowledge to resolve problems.

Skills and Requirements:

• Inflammation therapeutic area experience would be advantageous but not essential.
• Must have multinational (including EU) clinical trials experience including study management/coordination.
• Must have solid previous study management/coordination experience.
• Must have monitoring experience as site monitoring and/or co-monitoring will be required.
• Thorough knowledge and understanding of FDA and EU Regulations, ICH Guidelines, and GCPs governing the conduct of clinical trials is essential.
• Must be able to generally understand, interpret, and explain protocol requirements to others.
• Must be able to prioritize multiple tasks.
• Must be able to participate in multiple departmental or interdepartmental strategic initiatives under limited supervision.
• Must have a general, functional expertise to support SOP development and implementation.
• Must be able to resolve problems using national and international regulations, guidelines, and investigator interaction.
• Strong communication and influence skills and ability to create a clear sense of direction is necessary.
• International travel is required (up to approximately 20%)

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 Matthew Pike on +44 207 4400 639 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.