Clinical Project Manager – job description and person specification
· 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 Veryan’s CMO.
· Contribute to the ongoing scientific review of Veryan’s clinical database and draft or contribute to the preparation of manuscripts for regulatory and publication purposes.
· 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.
· 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 Veryan’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.
Education & Training
· Bachelor’s degree in a scientific or health-related field required
· Master’s degree in a scientific or health-related field preferred
· Project management
· Formal training in ICH-GCP regulations
· Relevant ACRP/ICR course attendance
· Risk-based monitoring in clinical trials
· Minimum of 7 years of general clinical research experience, including on-site monitoring
· 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
· Quality management system experience
· Risk Management (including FMECA)
To apply for this role, please send your CV and a covering email to Jo Graver, HR Manager.