Clinical Project Manager

Proclinical is working with an innovative medical device company that is seeking a Clinical Project Manager, to be based in Crawley on a permanent basis. The CPM ensures that all assigned clinical evaluations are designed and executed in according with timelines and budgets, in compliance with protocols, relevant legislation and regulations, GCP/ICH guidelines and company SOPs.

Job Responsibilities:

• Develop clinical study design concepts in line with the requirements of the business plan and work with internal and external resources to refine these plans into comprehensive clinical projects with associated implementation plans and budgets.
• Develop clinical study protocols and study related documentation.
• Implement approved clinical projects according to agreed budgets and milestones.
• Proactively identify sites for clinical investigation and conduct feasibility, qualification, initiation and visits as required to monitor compliance.
• Ensure that investigators and investigational site staff are provided with clinical case support as required to achieve the highest standard of proficiency in use of the Company's products and compliance with the study protocol(s).
• Regularly update all clinical project information databases and tracking systems in order to provide timely and accurate updates for management.
• Escalate medical issues to the company's CMO.
• Ensure that internal and external resources applied to each clinical project are managed efficiently and with effective oral and written communication throughout the project team.
• Contribute to the ongoing scientific review of the company's clinical database and draft or contribute to the preparation of manuscripts for regulatory and publication purposes.
• Work closely with the Clinical Data Manager to ensure data from all clinical projects is specified, captured, collected and queried appropriately within agreed specifications.
• Develop and maintain an effective and productive interface with the Company's CMO.
• Maintain an effective interface with the company's commercial operations to ensure the interface with clinical study sites and scientific advisors is managed professionally and is well-coordinated to build goodwill and business value.

Skills and Requirements:

• A Bachelor's degree in a scientific or health-related field is required.
• Master's degree in a scientific or health-related field is preferred
• Project management
• Formal training in ICH-GCP regulations.
• Relevant ACRP/ICR course attendance
• Risk-based monitoring in clinical trials
• At least 5 years of international (EU plus US) clinical study experience, ideally in medical devices
• At least 3 years' experience as a clinical project manager
• Medical device / cardiovascular intervention experience is preferred
• Advanced understanding of GCPs and ICH; European and international (OUS) clinical trial regulations and guidelines.
• Protocol writing experience required
• Fully proficient in use of MS Word, Excel, PowerPoint and clinical data management systems
• EDC system experience preferable

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 Jack O'Neill on +44 203 846 0646 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.

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